[Federal Register Volume 60, Number 93 (Monday, May 15, 1995)]
[Notices]
[Pages 25944-25976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11653]




[[Page 25943]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Public Health Service



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Specific List for Categorization of Laboratory Test Systems, Assays, 
and Examinations by Complexity; Notice

Federal Register / Vol. 60, No. 93 / Monday, May 15, 1995 / 
Notices  
[[Page 25944]] 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


Specific List for Categorization of Laboratory Test Systems, 
Assays, and Examinations by Complexity

agency: Public Health Service, HHS.

action: Notice with comment period.

-----------------------------------------------------------------------

summary: Regulations codified at 42 CFR 493.17, implementing the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 
100-578, require that the Secretary provide for the categorization of 
specific laboratory test systems, assays, and examinations by level of 
complexity. The criteria for such categorizations also are set forth in 
those regulations.
    A compiled list of approximately 12,000 specific clinical 
laboratory test systems, assays, and examinations categorized by level 
of complexity was published in the Federal Register on July 26, 1993 
(58 FR 39860). This notice contains responses to the comments submitted 
on those aspects of the July 26, 1993 publication that were subject to 
comment. This Notice also announces approximately 2900 additional test 
systems, assays, and examinations that have been categorized since the 
publication of the compiled test list. Included in this list of 
additional categorizations are those test systems which received 510(k) 
or premarket approval from the Food and Drug Administration (FDA) 
during the period from September 1, 1992 to March 15, 1995. Also 
included are additional test systems that were cleared prior to that 
period and noted by commenters as missing from the compiled test list.

dates: Effective date: The categorizations on this list were effective 
on the date of the test categorization notification letter sent to the 
manufacturer. Written comments on the tests initially categorized in 
this Notice will be considered if they are received at the address 
indicated below, by no later than 5 p.m. on June 14, 1995. CDC reserves 
the right to reevaluate and recategorize tests based on the comments 
received in response to this Notice.

addresses: Comments on the categorization of tests initially 
categorized in this Notice should be addressed to Public Health 
Service, Attention: CLIA Federal Register Notice, Centers for Disease 
Control and Prevention, Mail Stop F-11, 4770 Buford Highway, NE., 
Atlanta, Georgia 30341-3724.
    Due to staffing and resource limitations, we cannot accept 
facsimile (FAX) copies of comments. Nor can we accept comments by 
telephone.

for further information contact: Rosemary C. Bakes-Martin, (404) 488-
7655.

supplementary information: All requests for recategorization received 
during the 30 day comment period provided in the July 26, 1993 Federal 
Register notice (59 FR 39860) resulted in extensive review of available 
product information and the original complexity scoring for the 
individual test system, assay, or examination under consideration. If 
the requestor submitted new information, the test system was rescored 
taking into account the new information. Any changes in categorization 
or reasons for not making changes are addressed in this Notice under 
the section Comments and Responses.
    Comments in response to the July 26, 1993 Notice, that requested 
additional laboratory tests be waived of specific CLIA requirements, 
were deferred in light of the moratorium declared on classifying 
testing devices as waived tests on February 18, 1993. The CDC lifted 
the moratorium on waiver on December 19, 1994, and has now resumed 
reviewing requests for waiver status. On the date that the moratorium 
was lifted, a letter was sent to manufacturers of laboratory testing 
devices, that included guidelines that manufacturers may use to submit 
their requests for waiver. Requests for waiver will be evaluated in the 
order in which they are received.
    The public has requested that test categorization information be 
made available electronically. CDC is providing computer access to this 
information via the Internet. For further information regarding this 
capability, please call (404) 488-7655.

Comments and Responses
    Comment: A manufacturer requested clarification of what determines 
whether a testing device is subject to CLIA regulations. The commenter 
had concerns about measuring versus monitoring devices and ``in-vitro'' 
versus ``in-vivo'' testing.
    Response: All clinical laboratory tests performed on materials 
derived from the human body for the purpose of providing information 
for the diagnosis, prevention, or treatment of any disease, or the 
assessment of the health of, human beings are subject to CLIA 
regulations. The term ``derived from the human body'' refers to any 
specimen that is expelled from the human body, withdrawn by procedures 
such as phlebotomy, or, in the case of blood, diverted from the 
circulatory path. The circulatory path is defined as either the body's 
normal circulatory blood flow or a path established by a life-
sustaining apparatus such as the ``heart-lung'' machine. To be 
considered as a normal circulatory path, the ``heart-lung'' machine 
blood flow must be for the purpose of sustaining life and not for the 
purpose of performing testing. The examination of materials removed or 
diverted from either of these circulatory paths (normal or life 
sustaining) meets the definition of ``in-vitro'' testing and is subject 
to the CLIA regulations. An example of this type of procedure is ``ex-
vivo'' blood gas testing performed on a specimen diverted or removed by 
means of an indwelling radial catheter. (This indwelling catheter has 
not been established for the purpose of sustaining life and is outside 
the circulatory flow.) All tests that meet the definition of ``in-
vitro'' testing are subject to CLIA regulations. ``In-vivo'' testing, 
i.e. testing that is not removed or diverted from a normal or life 
sustaining circulatory path, is not subject to CLIA regulation at the 
present time. An example of this type of testing is pulse oximetry. 
Please note, however, that we are presently investigating the 
definitional and technical issues, and necessary revisions to the 
regulations that would make ``in-vivo'' testing subject to CLIA. Should 
it be determined at a later date that it is subject to CLIA, proper 
notice and opportunity for public comment will be provided before this 
testing is subject to CLIA regulation.
    The context in which the test results are being evaluated, i.e. 
monitoring versus measurement, is not a consideration for test 
complexity.
    Comment: A few manufacturers commented that some of their test 
systems should not be categorized for certain analytes because the 
company did not supply the reagents for performing these tests on the 
instruments listed.
    Response: Although the company which manufactures a test system may 
not have developed an assay procedure for a particular analyte, it is 
quite possible that another company could design an assay procedure 
that has been cleared by the FDA for use on the test system. In such a 
situation, the analyte will be listed as being available on the test 
system. If the assay developed by the reagent manufacturer does not 
perform as it should on the test system, it is the responsibility of 
the laboratory performing the testing or the manufacturer of the test 
system to inform the FDA.

[[Page 25945]]

    Comment: Abbott Laboratories commented that the compiled list 
published on July 26, 1993 in the Federal Register did not specifically 
state whether the analytes Toxoplasma gondii Antibodies, 
Cytomegalovirus Antibodies, and Rubella Antibodies on the Abbott IMX 
were for determining IgG, IgM, or total antibodies.
    Response: The analyte nomenclature for antibodies to 
cytomegalovirus, toxoplasmosis, and rubella does not specify that the 
antibodies are total, IgG, or IgM antibodies. In those instances where 
a kit is used to identify the antibodies, the test system name will 
frequently specify that the antibodies being detected are either total 
antibodies, or IgG or IgM specific antibodies. When the test system 
name does not include the specific antibody, as is the case with the 
automated analyzers, then the generic nomenclature for the antibody can 
refer to total or specific antibodies. We do not see this nomenclature 
as a problem because the test complexity for the procedure will be the 
same regardless of whether the antibodies being detected are total are 
specific antibodies.
    Comment: One organization, after learning of the recommendation by 
the Clinical Laboratory Improvement Advisory Committee (CLIAC) and 
subsequent move of some HDL procedures from high to moderate 
complexity, requested recategorization of HDL procedures back to high 
complexity. The organization felt that all HDL procedures should 
receive a complexity score of ``3'' for the criteria ``Training and 
Experience'' and ``Calibration, Quality Control or Proficiency Testing 
Materials.'' Another manufacturer requested that numerous HDL 
procedures be recategorized from high complexity to moderate 
complexity. Other commenters indicated that based upon the process for 
recategorization of 16 HDL procedures from high to moderate complexity 
announced in the July 26, 1993 Notice, there were some inconsistencies 
in the application of this process to other HDL procedures. The 
commenters felt that the reagent preparation requirements for some of 
the HDL procedures that remained high complexity were not sufficiently 
complicated to warrant a higher score than those HDL procedures that 
were recategorized to moderate complexity. The commenters requested 
that the scores of these HDL procedures be lowered from ``2'' to ``1'' 
in the criterion ``Reagents and Materials Preparation'' and that these 
procedures be recategorized from high complexity to moderate 
complexity.
    Response: In response to the continuing concerns regarding the 
categorization of HDL cholesterol, CDC once again reassessed the 
assigned scores for HDL as performed by automated methods. The original 
CLIAC discussion had focused on the question of the training and 
experience, and interpretation and judgment necessary for the analyst 
to make appropriate decisions (e.g., evaluation of the supernatant's 
turbidity in the pretreatment precipitation step) during the testing 
process. It was on this issue that CDC determined that analyst 
interaction was of a lesser degree for some automated methods than for 
others. Therefore, following the CLIAC recommendation for reevaluation 
of these score assignments, some HDL procedures were recategorized from 
high to moderate complexity. In response to the comments on the July 
26, 1993 test list that announced this group of recategorizations, we 
have reevaluated all HDL procedures for consistency in applying the 
criteria ``Reagents and Materials Preparation''. Under this criteria, a 
score of ``1'' is assigned when the manufacturer provides that analyst 
with an automated method of adding quantitative amounts of 
precipitating reagent to the sample so that analyst intervention is 
minimal, or when the manufacturer provides the analyst with a dedicated 
tube containing a single precipitating reagent. As a result of 
reevaluating the application of this criteria, the following HDL 
procedures have been recategorized from high complexity to moderate 
complexity: Abbott TDX, Abbott TDX FLX, Abbott Vision Non Whole Blood 
HDL Procedure, and the BioAutoMed ASCA.
    Comment: One commenter recommended the recategorization of 
``large'' hematology analyzers and microscopy procedures from moderate 
to high complexity.
    Response: Using the seven criteria established for categorization, 
automated hematology analyzers, in general, scored as moderate 
complexity. Although the large automated instruments used in hematology 
apply multiple principles in their operation, the instruments do not 
require extensive analyst intervention or highly specialized knowledge 
for operation. Microscopy procedures were also categorized by 
complexity using the criteria established for test categorization. 
Those procedures which do not require an extensive level of knowledge 
or training to perform the evaluation, or do not require an extensive 
level of judgment or interpretive skill to recognize or enumerate the 
cellular elements under evaluation, generally scored as moderate 
complexity.
    Comment: One manufacturer requested recategorization of some alpha-
fetoprotein procedures from high complexity to moderate complexity.
    Response: Material serum alpha-fetoprotein (AFP) procedures require 
extensive training, interpretation and judgment. The analyst must use 
patient information related to the weeks of gestation in conjunction 
with the procedure value to obtain a reportable result. Amniotic fluid 
specimens for AFP may require preanalytic testing to determine the 
presence of interfering substances which can lead to result 
misinterpretation or they may need manipulation of the sample to 
produce a clear supernatant. Extensive interpretive and judgment skills 
are also necessary to resolve technical problems, such as improper 
specimen collection, or determine the need for repeat testing. All of 
these considerations are in addition to those related to the 
methodology of the testing procedure. At the present time, all 
procedures for maternal serum AFP and amniotic fluid AFP score in the 
high complexity category.
    Comment: On professional organization voiced support for the high 
complexity scores given to any test that involves the interpretation of 
cultures and requires multiple steps for the achievement of accurate 
results. This organization suggested that other tests now categorized 
as moderate complexity should be categorized as high complexity for the 
same reasons. The example given was the direct Coombs test, which the 
organization indicated would yield a false negative result if the 
patient read blood cells were washed insufficiently.
    Response: We appreciate the organization's statement of support 
concerning the categorization scores of microbiology culture methods. 
In regard to the direct antiglobulin test (DAT), or direct Coombs, we 
feel that this assay is appropriately categorized as moderate 
complexity since the procedural skills are easily acquired, the 
reagents are stable and ready to use, and limited knowledge and 
judgment is required. The CLIA regulations to do relieve the laboratory 
of its responsibility to evaluate the competency of its staff or 
provide sufficient training on supervision for the correction of any 
technical deficiencies. Training on proper wash techniques to prevent 
false negative DAT results should be an integral part of the training 
of all analysts performing these procedures. We do not feel that the 
degree of [[Page 25946]] decision making, interpretation, and judgment 
required to perform a DAT approaches the level required to isolate and 
identify organisms from culture.
    Comment: Several commenters expressed confusion concerning the 
categorization of rapid strep test kits. Some referred to them as high 
complexity procedures.
    Response: Most of the tests that detect streptococcal antigen 
directly from a throat swab are categorized as moderate complexity 
tests. They require some knowledge, training and judgment to accurately 
perform the procedure. They are not categorized as high complexity 
tests because they do not require the level of knowledge, training, 
experience and interpretative skill that is required of a high 
complexity procedure such as isolation and identification of an 
organism from culture.
    Comment: Several commenters requested that throat and urine 
cultures, and urine susceptibility testing be recategorized from high 
to moderate complexity. A few other commenters agreed with high 
complexity categorization of microbiology cultures due to the advanced 
level of interpretation, judgment, knowledge, and experience required 
to obtain an accurate result when performing these procedures.
    Response: Isolation, identification, and susceptibility testing of 
microorganisms from culture is a complex process regardless of the 
source of the culture. It requires significant knowledge, training, and 
interpretation for the selection and performance of the individual test 
components in this process, which may include staining for microscopic 
evaluation, subculturing, and performing the appropriate biochemical 
analyses. Taking these factors into consideration when scoring for 
complexity, these test systems are appropriately categorized as high 
complexity.
    Comment: One commenter asked whether the use of general 
microbiology culture media, such as sheep blood agar, was categorized. 
There has also been some confusion as to whether inoculation of primary 
culture media or the determination of a ``No growth'' final culture 
result is considered a high complexity test.
    Response: Primary inoculation of microbiology culture media (e.g. 
blood agar, chocolate agar, MacConkey agar, heart infusion broth) is 
not considered a complete test system under the CLIA regulations. The 
process of isolation and identification from the primary culture is 
considered a total test system. The inoculation of the media becomes 
part of the test system when the primary media is observed to determine 
whether growth is present after an incubation period. We have 
previously stated that if a culture is read even to the point of 
providing a result of ``No growth'' it is considered to be an 
identification from culture, and, therefore, the laboratory reporting 
the result must be certified to perform the entire culture procedure. 
In response to the confusion as to whether the determination that there 
is either growth or no growth on primary culture plates, including the 
final reporting of a ``No growth'' culture result, falls into the 
moderate or high complexity category, we have created a new test system 
designation, (22167) ``Growth/No Growth of Bacteria on Solid Culture 
Media'', which is categorized as moderate complexity. This test system 
designation applies to a result determined after examining a culture 
from any body site, that was initially inoculated on solid culture agar 
or media. It does not apply to cultures inoculated into a broth medium 
such as heart infusion broth, thioglycollate medium, or to conventional 
broth blood cultures. Final reports for this moderate complexity test 
system are limited to ``Growth'', ``Growth--referred for identification 
or interpretation'', or ``No growth''. A result of ``No growth'' means 
that there are NO bacterial colonies on the media after incubation. The 
presence of ``normal flora'', contaminants, or any organism not 
considered a pathogen could not be interpreted or reported as ``No 
growth''.
    Individual biochemical tests that are performed as part of the 
total identification process (e.g. oxidase, catalase) are not 
categorized as separate tests. Those test systems or kits that usually 
contain a group of biochemical or serological tests, and result in the 
definitive identification of a microorganism are categorized. Several 
selective culture media that do not require transfer from the initial 
plate, and result in preliminary identification of a specific 
microorganism, have been categorized as moderate complexity tests. The 
degree of training and experience, judgment and interpretive skills 
required to recognize one specific colony type or reaction on these 
selective media is significantly less than what is required for 
selecting specific colonies from the growth on primary culture plates, 
and performing definitive identification tests on pure cultures of 
these organisms.
    Comment: One commenter requested that all of the test systems for 
dermatophytes that have been categorized and published as moderate 
complexity should be recategorized as high complexity due to the 
advanced level of interpretation, judgment, knowledge, and experience 
required to obtain an accurate result.
    Response: The test systems for dermatophytes that have been 
categorized as moderate complexity are tests performed on selective 
media that detect the presence or absence of dermatophytes, but do not 
identify these fungi. These test systems require significantly less 
knowledge, experience, interpretation, and judgment than high 
complexity cultures for isolation and complete identification of fungi, 
in which organisms must be transferred and identification procedures 
performed. Based on the information we have received to date, we 
believe that the test systems for dermatophytes using selective media 
are appropriately categorized as moderate complexity.
    Comment: Several commenters requested that the following analytes 
and test systems be recategorized from moderate to high complexity:

N. gonorrhoeae (from urogenital or rectal only)
    Test system--All presumpt. ID using select, media, oxidase, and 
gram stain
Streptococcus, group A (from throat only)
    Test system--All presumpt. ID w/selective media, hemolysis, and 
bacitracin

    Response: These two tests for presumptive identification of a 
single microorganism on selective media from culture of a specific body 
site were placed in the moderate complexity category because the 
knowledge, training, interpretation and judgment required is 
significantly less than that needed to distinguish multiple organisms 
and determine the presence of pathogens, normal flora, or contamination 
in a culture initially inoculated on general nonselective culture 
media. For these reasons, we disagree with these commenters, and these 
tests will remain categorized as moderately complex.
    Comment: One commenter requested that Gram stain procedures 
performed on endocervical specimens be recatogorized from moderate to 
high complexity.
    Response: Gram stains from urethral and endocervical smears are 
categorized as moderate complexity procedures, while Gram stains from 
other sources are categorized as high complexity procedures as 
determined by the scoring criteria established for test categorization. 
Smears from urethral and endocervical sources do not tend to 
[[Page 25947]] contain the variety of microorganisms or cell types that 
can be seen on smears taken from other sources. Therefore, the 
knowledge, training and experience, interpretation and judgment 
required to interpret a Gram stained smear from urethral or 
endocervical sources is not as extensive as that required to interpret 
gram stain smears from other sources. Although we agree that there is a 
difference in the interpretation and judgment required for Gram stained 
smears from urethral versus endocervical sources, we do not believe 
that difference is sufficient to place the Gram stain evaluations 
performed on endocervical smears into high complexity. This issue was 
presented to, and discussed by, CLIAC. The CLIAC felt that CDC's 
assessment of the level of difficulty for performing the evaluations 
was appropriate, thus the Gram stain of endocervical smears will remain 
in the moderate complexity category.
    Comment: One commenter requested that the MAST CLA-1 Luminometer 
System be recategorized from high to moderate complexity. The commenter 
noted that this is a different request from earlier correspondence 
requesting that the MAST Allergy Densitometer System be recategorized 
from high to moderate complexity.
    Response: We would like to emphasize that we assess the complexity 
of every analyte on each individual instrument and do not categorize 
instruments by complexity without analytes. Additionally, the entire 
testing process of preanalytic, analytic, and postanalytic steps, 
including the process for determination of results, are evaluated for 
categorization. Thus the instrument used to read the final results is 
not graded independently of the total testing process. The analytes for 
which the MAST CLA Allergy System has been categorized as a high 
complexity test system are ``allergen specific IgE'' and 
``immunoglobulins IgE''.
    As in our earlier response regarding the MAST CLA Allergy System, 
we maintain that high complexity is the appropriate complexity rating 
for the MAST CLA Allergy System. While it is true that there are two 
different means to measure test results for this procedure, i.e., by 
densitometer or by using the MAST Chemiluminescent Analyzer (CLA-1), 
these measuring devices do not significantly change the complexity of 
the entire testing process. Substantial training and experience are 
required to perform the complete procedure. The steps in the procedure 
are manually executed and are performed in the same way except for 
result reading and data reduction. Regardless of the reading system 
used, the analyst must prepare multiple reagents prior to testing, some 
of which require special handling; the process requires manual addition 
of specimen to the chamber using a syringe, followed by timed 
incubation, multiple wash steps, addition of reagents, a second timed 
incubation and more wash steps. It is only after these second wash 
steps are completed that the CLA-1 Chemiluminescent Analyzer automates 
the photodevelopment, result reading and data reduction, while the 
Densitometer system requires manual photodevelopment, followed by 
result reading and data reduction on the instrument.
    We have reviewed the MAST CLA Allergy System taking into account 
both methods of final result determination and have concluded that due 
to the knowledge, training and skills necessary to perform the IgE 
assays properly, this test system belongs in the high complexity 
category. However, for purposes of clarification, we have listed the 
system in this Notice in such way that the method of result 
determination is clearly specified, and it is now listed twice, as 
follows: (40176) MAST CLA Allergy System (densitometer) and (40177) 
MAST CLA-1 Chemiluminescent Allergy System. Both are categorized as 
high complexity.
    Comment: One commenter requested that the Scandipharm CF INDICATOR 
SWEAT TEST SYSTEM (CFIS) be given the same status as the physician-
performed microscopy procedures so that access to cystic fibrosis 
screening would not be restricted.
    Response: The Scandipharm CF INDICATOR SWEAT TEST SYSTEM (CFIS) 
does not meet the criteria for physician-performed microscopy 
procedures (PPM). The PPM examinations include only specific 
microscopic procedures performed on specimens that are derived from 
patients as part of the physical examination. We have received numerous 
comments suggesting that another level of complexity be established 
that is intermediate between waived and moderate complexity. HHS is 
taking these suggestions under advisement.

Additions to Waived Category

    The Ames Glucometer ENCORE QA Blood Glucose Meter (04423) and the 
Ames Glucometer QA Blood Glucose Meter (04422) have been deleted from 
the list of moderate complexity tests and have been added to the list 
of waived tests. Section Sec. 493.15(c) of the CLIA regulations lists 
``blood glucose by glucose monitoring devices cleared by the FDA 
specifically for home use'' as waived tests. The Ames Glucometers are 
glucose monitoring devices that were recently cleared by the FDA for 
home use; therefore, they are now listed as waived tests.
    Please note that in this list of additions to the CLIA test 
categorization list, we have included the test systems (58311) 
Separation Technology STI HemataStat II and (58309) Separation 
Technology STI HemataStat Model C70 under the analyte (9581) Spun 
Microhematocrit as waived procedures. On previous lists of waived 
procedures, we did not list individual test systems capable of 
obtaining results for spun hematocrit, but rather listed the all-
inclusive test system designation (04420) ``All Spun Microhematocrit 
Procedures''. The two Separation Technology test systems have been 
listed in response to requests from the public to clarify that these 
test systems are indeed spun microhematocrit procedures. The all-
inclusive test system designation (04420) will continue to be included 
on the waived list to indicate that, at the present time, all spun 
microhematocrit test systems are waived procedures. We do encourage the 
public to contact us if there are questions about whether other 
specific test systems meet this definition. In the future, we will 
include all test systems by manufacturer's name on the waived list.

Additions

    In this publication, we are announcing the categorization of two 
laboratory procedures that are normally performed in dental offices. 
The dental procedures for (4965) Proteolytic enzymes are listed in the 
speciality of General Chemistry, and for (1317) Dental plaque, in 
bacteriology.

Corrections

    The following corrections to the list of test systems, assays and 
examinations published previously in the Federal Register are based on 
supplemental information provided by the commenters during the comment 
period or as a result of corrections of data entry errors. The CDC 
should be notified of any changes in manufacture or test system names 
so that these changes can be included in the next published test list.
Scandipharm CF Indicator (58240):
    The Scandipharm CF Indicator (58240) (Cystic Fibrosis Sweat Test) 
has been deleted from the high complexity category and placed in the 
moderate complexity category based upon new [[Page 25948]] information 
supplied by the manufacturer regarding the sample collection. Previous 
information had indicated that the amount of analyst involvement in the 
collection of the sample was more extensive than that indicated in the 
new information. Upon evaluation of this information supplied by the 
manufacturer, it was determined that the training and experience and 
interpretation and judgment required by the analyst to successfully 
perform the sample collection is not as extensive as originally 
indicated. As a result of the adjustment of scores for relevant 
criteria, the Scandipharm CF Indicator now registers a total score that 
places it in the moderate complexity category.
International Technidyne Corporation:
    As noted in the preamble to the compiled test list, the analyte 
heparin was removed from the International Technidyne Corporation 
systems because the relevant analytes were either (2539) heparin dose 
response (HDR) or (2538) heparin/protamine titration (HPT). These 
systems were inadvertently omitted in the compiled test list for the 
analytes HDR or HPT. This error has been corrected in the database and 
the systems are listed in this Notice under the appropriate analytes.
(2502) HCG, Serum, Quantitative:
    The analyte, HCG, Serum, Quantitative, has been clarified as (2502) 
HCG, Beta, Serum, Quantitative.
(4945) Protamine Rate Titration (PRT)
    The analyte (4945) Protamine Rate Titration for the International 
Technidyne Hemochron test systems has been corrected to (4945) 
Protamine Response Test (PRT).
MicroProbe Affirm VP Identification Kit (40135) for the detection and 
identification of (2212) Gardnerella vaginalis:
    Identification of G. vaginalis using the MicroProbe Affirm VP 
Identification Kit is categorized as a moderate complexity test, and is 
correctly listed as such on page 39879 of the July 26, 1993 Federal 
Register notice, in the List of Previously Unpublished Categorizations. 
The erroneous listing of this analyte and test system as high 
complexity in the compiled test list of categorizations has been 
corrected in this Federal Register Notice.
Bio-Scan Bio-Gen:
    The manufacturer's name was inadvertently omitted from several 
entries for Bio-Gen test systems, listed under (9641) Urine Dipstick or 
Tablet Analytes, Nonautomated. These entries have been corrected to 
read Bio-Scan Bio-Gen in this notice.
Access Medical Systems ImmunoClone HCG Test (04377):
    An entry under HCG, Serum, Qualitative, was incorrectly listed as 
Access Medical Systems ImmunoClone (direct Ag/visual) (04311) and has 
been revised to read Access Medical Systems ImmunoClone HCG Test 
(04377).
bioMerieux Vitek Vidas (07434):
    The test system bioMerieux Vitek Vidas (07434) for the analyte 
(6111) Thyroxine, Free (FT4) has been revised to Vitek Systems Vidas 
(67038) for consistency in the listing of test systems, assays, and 
examinations.

Incorrect Test System Codes

    Incorrect test system codes were inadvertently assigned to several 
systems on the previous test list and have been corrected as follows:
    Gen-Probe Legionella Rapid Diag. Systems (including culture) was 
incorrectly assigned the test system code (22126). The correct code is 
(22160).
    Gen-Probe M. Pneumoniae Rapid Diag. Systems (including culture) was 
incorrectly assigned the test system code (22127). The correct code is 
(22161).
    Gull Laboratories RSV-Mab Test (direct antigen) was incorrectly 
assigned the test system code (22128). The correct code is (22162).
    Seradyn Colorvue--Giardia (direct Ag/visual) was incorrectly 
assigned the test system code (58100). The correct code is (58296).
    Seradyn Colorvue--Cryptosporidium (direct Ag/visual) was 
incorrectly assigned the test system code (58101). The correct code is 
(58297).

Deletions

(4023) Myoglobin:
    The analyte myoglobin was listed in both the General Chemistry and 
Immunology speciality areas. It has been deleted from the Immunology 
speciality area.
(0444) Anti-Reticulin Antibodies:
    Anti-Reticulin Antibodies on the Scimedx Auto Screen Test System 
(58016) has been deleted because it has not been cleared by FDA for use 
in the clinical laboratory.
(5503) Respiratory viruses (Influenza A&B, parainfluenza):
    The analyte Respiratory viruses (Influenza A&B, parainfluenza) has 
been deleted and replaced with the following analytes: (0410) 
Adenovirus, (2828) Influenza A, (2829) Influenza B, (4959) 
Parainfluenza 1, (4960) Parainfluenza 2, (4961) Parainfluenza 3, and 
(5503) Respiratory syncytial virus.
(0456) Antithrombin III (ATIII):
    Instrumentation Laboratory IL ACL 100 (28073) has been deleted from 
the analyte (0456) Antithrombin III (ATIII) because this analyte is not 
available on this system.
(0703) Beta-2 microglobulin:
    Du Pont Medical Products aca II (13172) has been deleted from the 
analyte beta-2 microglobulin because this analyte is not available on 
this system.
(4908) Platelet Count:
    The test systems Abbott Cell-Dyn 400 (04230), Abbott Cell-Dyn 500 
(04231), and Abbott Cell-Dyn 700 (04233) have been deleted from the 
analyte platelet count because these instruments do not analyze this 
analyte.

Analyte Nomenclature and Use

    We will use the term ``direct bilirubin'' to refer to the analyte 
``conjugated bilirubin''.
    Due to the different nomenclature systems associated with many flow 
cytometer analytes, we will list each analyte by the terminology 
furnished by the manufacturer.
    Thyroid Peroxidase Autoantibodies (TPO) and Anti-Thyroid Microsomal 
Antibodies (AMA) refer to the same analyte. To avoid confusion, we will 
list the analyte nomenclature used by the manufacturer in the package 
insert for the test system being categorized.
    For purposes of clarification, the analyte (1033) for Cortisol, 
Urine has been modified to read Cortisol, Urine (direct procedure), and 
a new analyte (1095) Cortisol, Urine (extraction procedure) has been 
established.

Speciality/Subspeciality Changes

    In previous publications of the Test Categorization List, analyte/
test systems were assigned to speciality/subspeciality categories based 
upon the most recognized area in the clinical laboratory where these 
procedures are generally performed. In an effort to coordinate 
regulatory responsibilities between the Health Care Financing 
Administration (HCFA) and the CDC, we have redefined the speciality/
subspeciality categories for some analytes to conform to HCFA's common 
procedure coding system for Medicare payment. Consequently, in this 
publication, you will note that the analytes (0476) Acetylcholine/
choline, [[Page 25949]] (0426) Aminoglycosides, (0705) Blood Lead, 
(1012) Carboxyhemoglobin, (2541) Histamine, and (3712) Lithium have 
been moved to Toxicology; the analytes (0424) Alpha Fetoprotein--tumor 
marker, (1051) C1-Esterase Inhibitor (C1INH), and (4927) Platelet 
Antibody--detection have been moved to General Immunology; the analytes 
(1049) Cancer Antigen 125 (CA125), (1013) Carcinoembryonic Antigen 
(CEA), (1015) Ceruloplasmin, (2511) Haptoglobin, (3717) Lysozyme, 
(4911) Prealbumin, (4919) Prostatic Specific Antigen (PSA), (4920) 
Protein Fractions, (6114) Transferrin, and (6129) Trypsin have been 
moved to General Chemistry; the analyte (4021) Malarial Parasite has 
been moved to Parasitology. Also, a number of analytes that were 
previously listed under the speciality of General Chemistry or the 
subspeciality of Toxicology are now listed under the subspeciality of 
Endocrinology. These analytes, with their respective codes, are:

(0106) 17 Ketosteroid
(0102) 17 OH Progesterone
(0103) 17 OH Progesterone, Neonatal
(0101) 5-Hydroxyindolacetic Acid (5-HIAA)
(0472) Adenosine Monophosphate, Cyclic (cAMP)
(0458) Adrenocorticotropic Hormone (ACTH)
(0459) Aldosterone
(0466) Androstanediol Glucuronide (3 alpha-diol G)
(0460) Androstenedione
(0479) Angiotensin I
(1040) Calcitonin
(1056) Catecholamines, Plasma
(1055) Catecholamines, Urine
(1032) Cortisol
(1033) Cortisol, Urine (direct procedure)
(1095) Cortisol, Urine (extraction procedure)
(1043) Cyclic AMP
(1309) Dehydroepiandrosterone (DHEA)
(1310) Dehydroepiandrosterone Sulfate (DHEA-SO4
(1611) Erythropoietin
(1605) Estradiol
(1606) Estriol-Total
(1607) Estriol-unconjugated
(1908) Follicle Stimulating Hormone (FSH)
(2205) Gastrin
(2206) Glucagon
(2502) HCG, Beta, Serum, Quantitative
(2501) HCG, Serum, Qualitative
(2555) HCG, Total, Serum, Quantitative
(2503) HCG, Urine, Qualitative (non-waived procedures)
(2534) HCG, Urine, Quantitative
(2543) HCG, Whole Blood, Qualitative
(2545) Homovanillic Acid (HVA)
(2547) Human Growth Hormone
(2533) Human Placental Lactogen (hPL)
(2812) Insulin
(2818) Insulin-like Growth Factor-1 (IGF-1)
(3713) Luteinizing Hormone (LH)
(4025) Metanephrines, Urine
(4934) Parathyroid Hormone--C-Terminal
(4924) Parathyroid Hormone--Intact
(4925) Parathyroid Hormone--Mid-molecule (PTH-M)
(4914) Progesterone
(4915) Prolactin
(5515) Renin
(5820) Serotonin
(5819) Sex Hormone Binding Globulin
(6102) Testosterone
(6122) Testosterone, Free
(6110) Thyroid Binding Globulin (TBG)
(6106) Thyroid Stimulating Hormone (TSH)
(6107) Thyroid Stimulating Hormone (TSH) (Neonatal)
(6108) Thyroid Stimulating Hormone--high sens. (TSH-HS)
(6109) Thyroxine (T4)
(6123) Thyroxine (T4), Neonatal
(6110) Thyroxine Binding Globulin (TBG)
(6111) Thyroxine, Free (FT4)
(6119) Triiodothyronine (T3)
(6120) Triiodothyronine Uptake (T3U) (TU)
(6121) Triiodothyronine, Free (FT3)
(6710) Vanillylmandelic Acid (VMA)

    Dated: May 2, 1995.
Philip R. Lee,
Assistant Secretary for Health.

List of Previously Unpublished Categorizations
    The test categorization scoring scheme was based on an assessment 
of the complexity of the operation of the test procedure and not on an 
evaluation of data documenting the procedure's performance over time. 
Therefore, the categorization of a test system, assay or examination as 
moderate or high complexity should not be interpreted as an indication 
of the acceptability or unacceptability of the accuracy, precision or 
overall performance of the procedure.

COMPLEXITY: MODERATE

SPECIALITY/SUBSPECIALITY: Bacteriology

ANALYTE: Aerobic &/or Anaerobic Organisms-unlimited sources (0412)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Difco ESP Blood Culturing System (13275)
    Growth/No Growth of Bacteria on Solid Culture Media (22167)
    Organon Teknika Bact/Alert 120 (46148)

ANALYTE: Aerobic Organisms from urine specimens only (0468)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Difco EZ Streak Urine Culture Device (colony court only) (13311)
    Savyon Diagnostic DIASLIDE (colony count only) (58290)
    Traditional Blood Agar Streak Plate (colony count only) (61131)
    Vitek Systems Bac-T-Screen 2000 (bacteriuria) (67039)
    Vitek Systems Bac-T-Screen 402A (bacteriuria) (67049)
    Vitek Systems Bac-T-Screen 500 (bacteriuria) (67050)

ANALYTE: Chlamydia (1016)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott TestPack Chlamydia (direct antigen/visual) (04518)
    Wampole Clearview Chlamydia (direct antigen/visual) (70140)

ANALYTE: Clostridium difficile (1022)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Meridian Diagnostics ImmunoCard C. difficile (dir.Ag/visual) 
(40165)

ANALYTE: Gardnerella vaginalis (2212)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    MicroProbe Affirm VP Microbial Identification Test Kit (40135)
    MicroProbe Affirm VPIII Microbial Identification Test (40163)

ANALYTE: Helicobacter pylori (2512)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Serim PyloriTek Test Kit (58338)

ANALYTE: Streptococcus, group A (5810)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Becton Dickinson Precise STREP A (direct antigen/visual) (07426)
    Syntron QuikPac Strep A (EIA) Test (direct antigen/visual) 
(58291)
    Wampole Clearview Strep A (direct antigen/visual) (70141)

ANALYTE: Streptococcus, group A (from throat only) (5828)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Medix Biotech BESTest Strep A (40193)
    Quidel QuickVue One-Step Strep A Test (52024)

ANALYTE: Streptococcus, group B (5811)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    BioStar Strep B OIA (direct antigen/visual) (07540)

ANALYTE: Vibrio cholerae (6716)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    New Horizons CholeraScreen (43084)

SPECIALITY/SUBSPECIALITY: Endocrinology

ANALYTE: Cortisol (1032)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim ES 300 AL (07524)
    Boehringer Mannheim Hitachi 914 (07546)
    Ciba Corning ACS 180 (10046)
    Cirrus Diagnostics Immulite (10159)
    Sanofi Pasteur Access Immunoassay System (58257)
    Schiapparelli Biosystems ACE Clinical Chemistry System 
(58288) [[Page 25950]] 
    Vitek Systems Vidas (67038)

ANALYTE: Cortisol, Urine (direct procedure) (1033)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott TDX (04071)
    Sanofi Pasteur Access Immunoassay System (58257)

ANALYTE: Dehydroepiandrosterone (DHEA) (1309)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Serono Baker SR 1 (58090)

ANALYTE: Dehydroepiandrosterone Sulfate (DHEA-SO4) (1310)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Cirrus Diagnostics Immulite (10159)

ANALYTE: Estradiol (1605)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Stratus II (07051)
    Baxter Stratus IIntellect (07376)
    Boehringer Mannheim ES 300 AL (07524)
    Ciba Corning ACS 180 (10046)
    Cirrus Diagnostics Immulite (10159)
    PB Diagnostics Systems OPUS (49001)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    TOSOH A1A-1200 (61040)
    TOSOH A1A-600 (61039)
    Vitek Systems Vidas (67038)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Estriol-unconjugated (1607)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Follicle Stimulating Hormone (FSH) (1908)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Boehringer Mannheim ES 300 AL (07524)
    Du Pont ACA III with aca plus Immunoassay System (13253)
    Du Pont ACA IV with aca plus Immunoassay System (13254)
    Du Pont ACA SX with aca plus Immunoassay System (13313)
    Du Pont ACA Star with aca plus Immunoassay System (13358)
    Du Pont ACA V with aca plus Immunoassay System (13255)
    Organon Teknika AuraFlex (46152)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Roche Cobas Core (55119)
    Sanofi Pasteur Access Immunoassay System (58257)
    Syva Vista Immunoassay System (58221)
    Vitek Systems Vidas (67038)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: HCG, Beta, Serum, Quantitative (2502)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Boehringer Mannheim ES 300 AL (07524)
    Du Pont ACA Star with aca plus Immunoassay System (13358)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Sanofi Pasteur Access Immunoassay System (58257)
    Syva Vista Immunoassay System (58221)
    Vitek Systems Vidas (67038)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: HCG, Serum, Qualitative (2501)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott TestPack PLUS hCG COMBO (04375)
    Access Medical Systems ImmunoCLONE hCG Test (04377)
    Applied Biotech SureStep Combo hCG (04528)
    Disease Detection International Pro-Step PT hCG (13271)
    Disease Detection International Pro-Step hCG (13270)
    King's Bay Prelude hCG Combo Kit (34062)
    Mainline Technology MAINLINE Confirms hCG (40190)
    Princeton BioMeditech BioSign hCG One Step Pregnancy Test 
(49080)
    Quidel QuickVue One-Step hCG Combo Test (52022)
    SA Scientific SAS Serum/Urine hCG (58283)
    Stanbio QuPid Plus hCG Pregnancy Test (58326)
    Syntron Bioresearch QuikPac II hCG Combo Kit (58353)
    TECH-CO Visual HCG Pregnancy Test (61099)
    True Medix Beta Spec hCG (61139)
    Unipath Clearview HCG DUO (64031)

ANALYTE: HCG, Total, Serum, Quantitative (2555)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ciba Corning ACS 180 (10046)
    PB Diagnostics Systems OPUS (49001)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)

ANALYTE: HCG, Urine, Qualitative (non-waived procedures) (2503)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Applied Biotech Pregslide HCG Test (04498)
    Diagnostic Specialties Pregna-Cert (13276)
    J & S Medical Accutex B-HCG Latex Test (31011)
    SA Scientific SAS Direct Monoclonal hCG (58319)
    SA Scientific SAS Monoclonal HCG-Slide (58281)

ANALYTE: Human Growth Hormone (GH) (2547)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Insulin (2812)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim ES 300 AL (07524)

ANALYTE: Luteinizing Hormone (LH) (3713)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Boehringer Mannheim ES 300 AL (07524)
    Du Pont ACA III with aca plus Immunoassay System (13253)
    Du Pont ACA IV with aca plus Immunoassay System (13254)
    Du Pont ACA Star with aca plus Immunoassay System (13358)
    Du Pont ACA V with aca plus Immunoassay System (13255)
    Organon Teknika AuraFlex (46152)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Roche Cobas Core (55119)
    Sanofi Pasteur Access Immunoassay System (58257)
    Syva Vista Immunoassay System (58221)
    Vitek Systems Vidas (67038)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Parathyroid Hormone--Intact (4924)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Cirrus Diagnostics Immulite (10159)

ANALYTE: Progesterone (4914)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Stratus II (07051)
    Baxter Stratus IIntellect (07376)
    Boehringer Mannheim ES 300 AL (07524)
    Ciba Corning ACS 180 (10046)
    Cirrus Diagnostics Immulite (10159)
    TOSOH A1A-1200 (61040)
    TOSOH A1A-600 (61039)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Prolactin (4915)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Boehringer Mannheim ES 300 AL (07524)
    Cirrus Diagnostics Immulite (10159)
    Du Pont ACA III with aca plus Immunoassay System (13253)
    Du Pont ACA IV with aca plus Immunoassay System (13254)
    Du Pont ACA SX with aca Immunoassay System (13313)
    Du Pont ACA Star with aca plus Immunoassay System (13358)
    Du Pont ACA V with aca plus Immunoassay System (13255)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Roche Cobas Core (55119)
    Sanofi Pasteur Access Immunoassay System (58257)
    Syva Vista Immunoassay System (58221)
    Vitek Systems Vidas (67038)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Sex Hormone Binding Globulin (5819)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Cirrus Diagnostics Immulite (10159)

ANALYTE: Testosterone (6102)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ciba Corning ACS 180 (10046)

ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)
    TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25951]] 
    Bio-Rad RADIAS System (07493)
    Cirrus Diagnostics Immulite (10159)
    Du Pont ACA Star with aca plus Immunoassay System (13358)
    Organon Teknika AuraFlex (46152)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Roche Cobas Core (55119)
    Vitek Systems Vidas (67038)
    Wallac OY AutoDELFIA (70167)

ANALYTE: Thyroid Stimulating Hormone (TSH) (Neonatal) (6107)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad RADIAS System (07493)

ANALYTE: Thyroid Stimulating Hormone--high sens. (TSH-HS) (6108)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad RADIAS System (07493)
    Boehringer Mannheim ES 300 AL (07524)
    Sanofi Pasteur Access Immunoassay System (58257)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Thyroxine (T4) (6109)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Beckman Synchron CX 5 CE (07491)
    Becton Dickinson IQ Immunochemical System (07429)
    Boehringer Mannheim ES 300 AL (07524)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Organon Teknika AuraFlex (46152)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Roche Cobas Core (55119)
    Sanofi Pasteur Access Immunoassay System (58257)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)
    Vitek Systems Vidas (67038)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Thyroxine Binding Globulin (TBG) (6110)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim ES 300 AL (07524)
    Technicon Immuno 1 System (61042)

ANALYTE: Thyroxine Uptake (T4U) (TU) (6139)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont Dimension XL (13355)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Syva Vista Immunoassay System (58221)
    Vitek Systems Vidas (67038)

ANALYTE: Thyroxine, Free (FT4) (6111)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Bio-Rad RADIAS System (07493)
    Boehringer Mannheim ES 300 AL (07524)
    Cirrus Diagnostics Immulite (10159)
    Organon Teknika AuraFlex (46152)
    PB Diagnostics Systems OPUS (49001)
    Roche Cobas Core (55119)
    Sanofi Pasteur Access Immunoassay System (58257)
    Technicon Immuno 1 System (61042)
    Vitek Systems Vidas (67038)
    Wallac Oy AutoDELFIA (60167)

ANALYTE: Triiodothyronine (T3) (6119)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Boehringer Mannheim ES 300 AL (07524)
    Organon Teknika AuraFlex (46152)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Roche Cobas Core (55119)
    Sanofi Pasteur Access Immunoassay System (58257)
    TOSOH A1A-120DX (61154)
    Vitek Systems Vidas (67038)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: Triiodothyronine Uptake (T3U) (TU) (6120)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott TDX FLx (04072)
    Beckman Synchron CX 5 CE (07491)
    Becton Dickinson IQ Immunochemical System (07429)
    Boehringer Mannheim ES 300 AL (07524)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Organon Teknika AuraFlex (46152)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Sanofi Pasteur Access Immunoassay System (58257)

SPECIALITY/SUBSPECIALITY: General Chemistry

ANALYTE: Acid Phosphatase (0407)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 500 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)

ANALYTE: Alanine Aminotransferase (ALT) (SGPT) (0404)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Albumin (0414)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34504)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Albumin, Urinary (0516)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA II (13172)
    Du Pont ACA III (13173)
    Du Pont ACA IV (13083)
    Du Pont ACA Star (13357)
    Du Pont ACA V (13084)

ANALYTE: Aldolase (0415)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Alkaline Phosphatase (ALP) (0416)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056) [[Page 25952]] 
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Alpha-Hydroxybutyrate Dehydrogenase (HBDH) (0419)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Du Pont ACA Star (13357)

ANALYTE: Ammonia, Plasma/Serum (0427)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Abbott VP (04082)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 CE (07491)
    Beckman Synchron CX 7 (07073)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)

ANALYTE: Amylase (0429)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Amylase, pancreatic isoenzymes (p-Amylase) (0500)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 4 (07071)
    Beckman Synchron CX 5 (07072)
    Boehringer Mannheim Hitachi 704 (07161)
    Boehringer Mannheim Hitachi 705 (07162)
    Boehringer Mannheim Hitachi 717 (07163)
    Boehringer Mannheim Hitachi 747 (07166)
    Boehringer Mannheim Hitachi 911 (07377)

ANALYTE: Apolipoprotein A1 (0462)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)
    Instrumentation Laboratory IL Monarch 1000 (28082)
    Instrumentation Laboratory IL Monarch 2000 (28231)
    Instrumentation Laboratory IL Monarch Plus (28083)
    Olympus AU 5041 (46145)

ANALYTE: Apolipoprotein B (0457)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)
    Olympus AU 5041 (46145)

ANALYTE: Aspartate Aminotransferase (AST) (SGOT) (0405)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abaxis EPOC 2000 (04547)
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5131 (46088)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Bilirubin, Direct (0704)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCS (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    LSI ASCA Chemistry System (37069)
    Olmpus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Bilirubin, Neonatal (0705)
TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Du Pont ACA Star (13357)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem DT II (34057)

ANALYTE: Bilirubin, Total (0706)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abaxis EPOC 2000 (04547)
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Techicon OPERA Clinical Chemistry System (61161)

ANALYTE: Blood Gases with pH (0708)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AVL Compact 1 (04552)
    AVL Compact 2 (04555)
    AVL OPTI 1 (04572)
    Ciba Corning 248 (10260)
    Ciba Corning 840 (10250)
    Ciba Corning 845 (10296)
    Ciba Corning 850 (10251)
    Ciba Corning 855 (10297)
    Ciba Corning 860 (10269)
    Ciba Corning 865 (10298)
    Diametrics Medical DMI Blood Gas Analyzer (13274)
    Diametrics Medical IRMA Blood Analysis System (13362)
    I-STAT i-STAT 200 System (28344)
    I-STAT i-STAT Portable Clinical Analyzer (28186)
    Instrumentation Laboratory Blood Gas 1610 (28335)
    Instrumentation Laboratory Blood Gas 1620 (28336)
    Instrumentation Laboratory Blood Gas 1630 (28337)
    Instumentation Laboratory Blood Gas 1640 (28338)
    Instrumentation Laboratory Blood Gas 1650 
(28339) [[Page 25953]] 
    Instrumentation Laboratory IL 1430 BGElectrolyte (28343)
    Nova Stat profile 7 (43035)
    Nova Stat Profile 9 (43086)
    Nova Stat Profile Plus 10 (43063)
    Nova Stat Profile Ultra 11P Analyzer (43101)
    PPG Industries StatPal II Blood Gas Analysis System (49092)
    Radiometer ABL 5 (55136)
    Radiometer ABL 620 (55137)

ANALYTE: Blood pH (no blood gases) (07221)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AVL 9110 pH Analyzer (04523)
    AVL 988-4 (04556)
    Ionetics Model 400/450 Electrolyte Analyzer (28324)
    Medica EasyLyte Calcium Analyzer (40197)

ANALYTE: Calcium, Ionized (1004)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AVL 988-4 (04556)
    Ciba Corning 850 (10251)
    Ciba Corning 855 (10297)
    Ciba Corning 860 (10269)
    Ciba Corning 865 (10298)
    Diametrics Medical IRMA Blood Analysis System (13362)
    I-STAT i-STAT 200 System (28344)
    I-STAT i-STAT Portable Clinical Analyzer (28186)
    Instrumentation Laboratory Blood Gas 1640 (28338)
    Ionetics Model 400/450 Electrolyte Analyzer (28324)
    Medica EasyLyte Calcium Analyzer (40197)
    Nova Stat Profile 9 (43086)
    Nova Stat Profile Ultra 11P Analyzer (43101)
    Radiometer ABL 620 (55137)
    Radiometer EML 100 (55134)

ANALYTE: Calcium, Total (1005)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron AS-X (07069)
    Beckman Synchron CX 3 Delta (07548)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Nova 10 (with CRT) (43061)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Carbon Dioxide, Total (CO<INF>2) (1003)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 3 Delta (07548)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Nova 16 (43103)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Carcinoembryonic Antigen (CEA) (1013)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim ES 300 (07160)
    TOSOH A1A-600 (61039)

ANALYTE: Cerebrospinal Fluid (CSF) Protein (1014)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 4 (07071)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 (07072)
    Beckman Synchron CX 7 (07073)
    Boehringer Mannheim Hitachi 704 (07161)
    Boehringer Mannheim Hitachi 717 (07163)
    Boehringer Mannheim Hitachi 747 (07166)
    Boehringer Mannheim Hitachi 911 (07377)
    Du Pont ACA Star (13357)
    Du Pont Dimension (13086)
    Du Pont Dimension AR (13087)
    Du Pont Dimension ES (13215)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)

ANALYTE: Ceruloplasmin (1015)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)

ANALYTE: Chloride (1018)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 3 Delta (07548)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Ciba Corning 850 (10251)
    Ciba Corning 855 (10297)
    Ciba Corning 860 (10269)
    Ciba Corning 865 (10298)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    I-STAT i-STAT 200 System (28344)
    Instrumentation Laboratory Blood Gas 1650 (28339)
    Instrumentation Laboratory IL 1430 BGElectrolyte (28343)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Instrumentation Laboratory ILyte Na, K, C1 System (28320)
    Ionetics Model 400/450 Electrolyte Analyzer (28324)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Nova 10 (with CRT) (43061)
    Nova 16 (43103)
    Nova Stat Profile 9 (43086)
    Nova Stat Profile Plus 10 (43063)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Radiometer ABL 620 (55137)
    Radiometer EML 100 (55134)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Chloride, Sweat (Cystic Fibrosis Sweat Test) (1019)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Scandipharm CF Indicator (9800) (58240)

ANALYTE: Cholesterol (1020)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    StatChem StatTest Sysem (58269)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Cholinesterase (1021)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546) [[Page 25954]] 
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    Technicon Chem 1 (61003)
    Technicon Chem 1 Plus (61036)

ANALYTE: Creatine Kinase (CK) (1034)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PB Diagnostics Systems OPUS (49001)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont ACA Star with aca plus Immunoassay System (13358)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II 34057)
    LSI ASCA Chemistry System (37069)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Princeton BioMeditech AccuSign MI CK-MB/Myoglobin (49143)
    Princeton BioMeditech CarePoint MI CK-MB/Myoglobin (49141)
    Princeton BioMeditech LifeSign MI CK-MB/Myoglobin (49140)
    Princeton BioMeditech VitalSign MI CK-MB/Myoglobin (49142)
    Sanofi Pasteur Access Immunoassay System (58257)

ANALYTE: Creatinine (1035)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 3 Delta (07548)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Nova 16 (43103)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Ferritin (1902)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Bio-Rad RADIAS System (07493)
    Boehringer Mannheim ES 300 AL (07524)
    Cirrus Diagnostics Immulite (10159)
    Du Pont ACA III with aca plus Immunoassay System (13253)
    Du Pont ACA IV with aca plus Immunoassay System (13254)
    Du Pont ACA Star with aca plus Immunoassay System (13358)
    Du Pont ACA V with aca plus Immunoassay System (13255)
    Olympus Reply (46089)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Roche Cobas Core (55119)
    Roche Cobas FARA (55040)
    Roche Cobas FARA II (55041)
    Roche Cobas Mira Plus (55096)
    Sanofi Pasteur Access Immunoassay System (58257)
    Seradyn LPIA-100 (58294)
    Syva Vista Immunoassay System (58221)
    Vitek Systems Vidas (67038)

ANALYTE: Folate (Folic acid) (1907)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad RADIAS System (07493)
    Boehringer Mannheim Hitachi 911 (07377)
    Cirrus Diagnostics Immulite (10159)
    Roche Cobas Mira Plus (55096)
    Sanofi Pasteur Access Immunoassay System (58257)
    Syva Vista Immunoassay System (58221)

ANALYTE: Folate, Red Blood Cell (RBC Folate) (1930)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ciba Corning ACS 180 (10046)
    Sanofi Pasteur Access Immunoassay System (58257)

ANALYTE: Fructosamine (1914)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim Hitachi 736 (07164)
    Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Gamma Glutamyl Transferase (GGT) (2201)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Glucose (2203)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abaxis EPOC 2000 (04547)
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 3 Delta (07548)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Cholestech L.D.X. (10170)
    Ciba Corning 860 (10269)
    Ciba Corning 865 (10298)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    I-STAT i-STAT 200 System (28344)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Nova 16 (43103)
    Nova Stat Profile 9 (43086)
    Nova Stat Profile Plus 10 (43063)
    Nova Stat Profile Ultra 11P Analyzer (43101)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    StatChem StatTest System (58269) [[Page 25955]] 
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)
    Yellow Springs YSI Model 23A Blood Glucose Analyzer (76006)

ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott IMX (04056)
    Beckman Synchron CX 4 (07071)
    Beckman Synchron CX 5 (07072)
    Beckman Synchron CX 7 (07073)
    Bio-Rad RADIAS System (07493)
    Bio-Rad Variant (07498)
    Boehringer Mannheim Hitachi 704 (07161)
    Boehringer Mannheim Hitachi 717 (07163)
    Boehringer Mannheim Hitachi 747 (07166)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Roche Cobas FARA (55040)
    Roche Cobas Mira (55044)

ANALYTE: HDL Cholesterol (2550)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum (DMA One Shots) (04598)
    Abbott Spectrum (MHS SPINPRO) (04563)
    Abbott Spectrum (T-Am. Singles) (04588)
    Abbott Spectrum CCX (DMA One Shots) (04599)
    Abbott Spectrum CCX (T-Am. Singles) (04587)
    Abbott Spectrum EPX (DMA One Shots) (04600)
    Abbott Spectrum EPX (MHS SPINPRO) (04564)
    Abbott Spectrum EPX (T-Am. Singles) (04565)
    Abbott Spectrum Series II (DMA One Shots) (04601)
    Abbott Spectrum Series II (MHS SPINPRO) (04566)
    Abbott Spectrum Series II (T-Am. Singles) (04589)
    Abbott Spectrum Series II CCX (DMA One Shots) (04602)
    Abbott Spectrum Series II CCX (MHS SPINPRO) (04567)
    Abbott Spectrum Series II CCX (T-Am. Singles) (04590)
    Abbott TDX (04071)
    Abbott TDX (MHS SPINPRO) (04568)
    Abbott TDX FLx (04072)
    Abbott TDX FLx (MHS SPINPRO) (04569)
    Abbott VP (DMA One Shots) (04603)
    Abbott VP (MHS SPINPRO) (04570)
    Abbott Vision, Non Whole Blood HDL Procedure (04451)
    Abbott Vision, Non Whole Blood HDL Procedure (MHS SPINPRO) 
(04571)
    Ames Seralyzer (DMA One Shots) (04604)
    Ames Seralyzer III (DMA One Shots) (04605)
    Baxter Paramax (DMA One Shots) (07618)
    Baxter Paramax (MHS SPINPRO) (07566)
    Baxter Paramax 720 ZX (DMA One Shots) (07619)
    Baxter Paramax 720 ZX (MHS SPINPRO) (07567)
    Beckman Astra 8 (MHS SPINPRO) (07568)
    Beckman Astra 8e (MHS SPINPRO) (07569)
    Beckman Astra Ideal (MHS SPINPRO) (07570)
    Beckman Synchron AS-X (MHS SPINPRO) (07571)
    Beckman Synchron AS-Xe (MHS SPINPRO) (07572)
    Beckman Synchron AS Xi (MHS SPINPRO) (07573)
    Beckman Synchron CX 4 (DMA One Shots) (07620)
    Beckman Synchron CX 4 (MHS SPINPRO) (07574)
    Beckman Synchron CX 4 CE (DMA One Shots) (07621)
    Beckman Synchron CX 4 CE (MHS SPINPRO) (07575)
    Beckman Synchron CX 5 (DMA One Shots) (07622)
    Beckman Synchron CX 5 (MHS SPINPRO) (07576)
    Beckman Synchron CX 5 (T-Am. Singles) (07577)
    Beckman Synchron CX 5 CE (DMA One Shots) (07623)
    Beckman Synchron CX 7 (DMA One Shots) (07624)
    Beckman Synchron CX 7 (MHS SPINPRO) (07578)
    Beckman Synchron CX 7 (T-Am. Singles) (07579)
    Bio-Chem Laboratory Systems ATAC 2000/2100 (DMA One Shots) 
(07634)
    Bio-Chem Laboratory Systems ATAC 6000 (DMA One Shots) (07626)
    Bio-Chem Laboratory Systems ATAC 6000 (T-Am. Singles) (07596)
    BioAutoMed ASCA (07192)
    BioAutoMed ASCA (DMA One Shots) (07625)
    Boehringer Mannheim Hitachi 704 (DMA One Shots) (07627)
    Boehringer Mannheim Hitachi 704 (MHS SPINPRO) (07580)
    Boehringer Mannheim Hitachi 704 (T-Am. Singles) (07590)
    Boehringer Mannheim Hitachi 705 (DMA One Shots) (07628)
    Boehringer Mannheim Hitachi 705 (MHS SPINPRO) (07581)
    Boehringer Mannheim Hitachi 705 (T-Am. Singles) (07591)
    Boehringer Mannheim Hitachi 717 (DMA One Shots) (07629)
    Boehringer Mannheim Hitachi 717 (MHS SPINPRO) (07582)
    Boehringer Mannheim Hitachi 717 (T-Am. Singles) (07592)
    Boehringer Mannheim Hitachi 736 (DMA One Shots) (07630)
    Boehringer Mannheim Hitachi 736 (MHS SPINPRO) (07583)
    Boehringer Mannheim Hitachi 736 (T-Am. Singles) (07593)
    Boehringer Mannheim Hitachi 737 (DMA One Shots) (07631)
    Boehringer Mannheim Hitachi 737 (MHS SPINPRO) (07584)
    Boehringer Mannheim Hitachi 737 (T-Am. Singles) (07594)
    Boehringer Mannheim Hitachi 747 (DMA One Shots) (07632)
    Boehringer Mannheim Hitachi 747 (MHS SPINPRO) (07585)
    Boehringer Mannheim Hitachi 747 (T-Am. Singles) (07595)
    Boehringer Mannheim Hitachi 911 (MHS SPINPRO) (07586)
    Ciba Corning 550 Express (DMA One Shots) (10291)
    Ciba Corning 550 Express (MHS SPINPRO) (10274)
    Ciba Corning 550 Express (T-Am. Singles) (10273)
    Ciba Corning 570 Alliance (MHS SPINPRO) (10275)
    Ciba Corning 580 Alliance (MHS SPINPRO) (10276)
    Coulter Dacos (DMA One Shots) (10292)
    Coulter Dacos (T-Am. Singles) (10277)
    Coulter Optichem (T-Am. Singles) (10278)
    Coulter Optichem 100 (DMA One Shots) (10293)
    Du Pont ACA (DMA One Shots) (13365)
    Du Pont ACA (MHS SPINPRO) (13346)
    Du Pont ACA II (DMA One Shots) (13366)
    Du Pont ACA II (MHS SPINPRO) (13347)
    Du Pont ACA III (DMA One Shots) (13367)
    Du Pont ACA III (MHS SPINPRO) (13348)
    Du Pont ACA IV (DMA One Shots) (13368)
    Du Pont ACA IV (MHS SPINPRO) (13349)
    Du Pont ACA V (DMA One Shots) (13369)
    Du Pont ACA V ((MHS SPINPRO) (13350)
    Du Pont Analyst (DMA One Shots) (13364)
    Du Pont Analyst (MHS SPINPRO) (13351)
    Du Pont Dimension (DMA One Shots) (13370)
    Du Pont Dimension (MHS SPINPRO) (13352)
    Du Pont Dimension AR (DMA One Shots) (13371)
    Du Pont Dimension AR (MHS SPINPRO) (13353)
    Du Pont Dimension ES (DMA One Shots) (13372)
    Du Pont Dimension ES (MHS SPINPRO) (13354)
    EM Diagnostic Systems EPOS (DMA One Shots) (16099)
    EM Diagnostic Systems EPOS (MHS SPINPRO) (16094)
    Electronucleonics Gem-Profiler (DMA One Shots) (16095)
    Electronucleonics Gemini (DMA One Shots) (16096)
    Electronucleonics Gemstar (DMA One Shots) (16097)
    Electronucleonics Gemstar (T-Am. Singles) (16093)
    Electronucleonics Gemstar II (DMA One Shots) (16098)
    Instrumentation Laboratory IL Monarch (T-Am. Singles) (28361)
    Instrumentation Laboratory IL Monarch 1000 (DMA One Shots) 
(28380)
    Instrumentation Laboratory IL Monarch 1000 (T-Am. Singles) 
(28362)
    Instrumentation Laboratory IL Monarch 2000 (DMA One Shots) 
(28381)
    Instrumentation Laboratory IL Monarch 2000 (T-Am. Singles) 
(28363)
    Instrumentation Laboratory IL Monarch Plus (DMA One Shots) 
(28382)
    Instrumentation Laboratory IL Monarch Plus (T-Am. Singles) 
(28364)
    Kodak Ektachem 250 (DMA One Shots) (34076)
    Kodak Ektachem 250 (MHS SPINPRO) (34063)
    Kodak Ektachem 400 (DMA One Shots) (34077)
    Kodak Ektachem 400 (MHS SPINPRO) (34064)
    Kodak Ektachem 500 (DMA One Shots) (34078)
    Kodak Ektachem 500 (MHS SPINPRO) (34065)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 550 XRC Analyzer (DMA One Shots) 
(34079) [[Page 25956]] 
    Kodak Ektachem 700 (DMA One Shots) (34080)
    Kodak Ektachem 700 (MHS SPINPRO) (34066)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 700 Analyzer C Series (DMA One Shots) (34081)
    Kodak Ektachem 700 P (DMA One Shots) (34082)
    Kodak Ektachem 700 P (MHS SPINPRO) (34067)
    Kodak Ektachem 700 XR (DMA One Shots) (34083)
    Kodak Ektachem 700 XR (MHS SPINPRO) (34068)
    Kodak Ektachem 750 XRC (DMA One Shots) (34084)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT 60 (DMA One Shots) (34085)
    Kodak Ektachem DT 60 (MHS SPINPRO) (34069)
    Kodak Ektachem DT II (34057)
    Kodak Ektachem DT II (DMA One Shots) (34086)
    LSI ASCA Chemistry System (37069)
    LSI ASCA Chemistry System (DMA One Shots) (37096)
    LSI ASCA Chemistry System (T-Am. Singles) (37095)
    Olympus AU 5000 (DMA One Shots) (46173)
    Olympus AU 5021 (DMA One Shots) (46174)
    Olympus AU 5031 (DMA One Shots) (46175)
    Olympus AU 5041 (DMA One Shots) (46176)
    Olympus AU 5061 (DMA One Shots) (46177)
    Olympus AU 5121 (DMA One Shots) (46178)
    Olympus AU 5131 (DMA One Shots) (46179)
    Olympus AU 5200 (DMA One Shots) (46180)
    Olympus AU 5211 (DMA One Shots) (46181)
    Olympus AU 5221 (DMA One Shots) (46182)
    Olympus AU 5223 (DMA One Shots) (46183)
    Olympus AU 5231 (DMA One Shots) (46184)
    Olympus AU 800 (DMA One Shots) (46185)
    Olympus AU 5000 (MHS SPINPRO) (46161)
    Olympus AU 5000 (T-Am. Singles) (46166)
    Olympus Demand (DMA One Shots) (46186)
    Olympus Demand (MHS SPINPRO) (46162)
    Olympus Demand (T-Am. Singles) (46164)
    Olympus Reply (DMA One Shots) (46187)
    Olympus Reply (MHS SPINPRO) (46163)
    Olympus Reply (T-Am. Singles) (46165)
    Olympus Reply/AU560 (DMA One Shots) (46188)
    PrismaSystems PROCHEM (49105)
    Roche Cobas Bio (DMA One Shots) (55152)
    Roche Cobas Bio (MHS SPINPRO) (55140)
    Roche Cobas Bio (T-Am. Singles) (55143)
    Roche Cobas FARA (DMA One Shots) (55153)
    Roche Cobas FARA II (DMA One Shots) (55154)
    Roche Cobas Fara (MHS SPINPRO) (55141)
    Roche Cobas Fara (T-Am. Singles) (55144)
    Roche Cobas MIRA (DMA One Shots) (55155)
    Roche Cobas MIRA Plus (DMA One Shots) (55156)
    Roche Cobas MIRA S (DMA One Shots) (55157)
    Roche Cobas Mira (MHS SPINPRO) (55142)
    Roche Cobas Mira (T-Am. Singles) (55145)
    Schiapparelli Biosystems ACE (DMA One Shots) (58357)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon Assist (DMA One Shots) (61181)
    Technicon RA 100 (DMA One Shots) (61182)
    Technicon RA 1000 (DMA One Shots) (61183)
    Technicon RA 1000 (MHS SPINPRO) (61162)
    Technicon RA 1000 (T-Am. Singles) (61164)
    Technicon RA 2000 (DMA One Shots) (61184)
    Technicon RA 500 (DMA One Shots) (61185)
    Technicon RA 500 (T-Am. Singles) (61163)
    Technicon RA XT (DMA One Shots) (61186)
    Technicon RA XT (T-Am. Singles) (61165)

ANALYTE: Haptoglobin (2511)
    TEST SYSTEM, ASSAY OR EXAMINATION
    Behring Nephelometer II (07563)

ANALYTE: Hemoglobin S (2536)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Histo-Med Sickle Cell Reagent Set (25164)

ANALYTE: Iron (2814)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT SC Module (34017)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Iron Binding Capacity, Unsat. (UIBC) no pretreat. (2823)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim Hitachi 914 (07546)

ANALYTE: Lactate Dehydrogenase (LDH) (3701)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Lactate Dehydrogenase Heart Fraction (LDH-1) (3702)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)

ANALYTE: Lactate Dehydrogenase Liver Fraction (LLDH) 3703)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)

ANALYTE: Lactic Acid (Lactate) (3704)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Ciba Corning 860 (10269)
    Ciba Corning 865 (10298)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    Nova Stat Profile 9 (43086)
    Nova Stat Profile Plus 10 (43063)
    Nova Stat Profile Ultra 11P Analyzer (43101)
    Technicon OPERA Clinical Chemistry System (61161)
    Yellow Springs YSI Model 23L Blood Lactoat Analyzer (76007)

ANALYTE: Lactoferrin (3727)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    TechLab LEUKO-TEST (61133)
    Touch Scientific LactoCard Tear Lactoferrin Immunoassay 
(61110) [[Page 25957]] 
    Touch Scientific Lactoferrin MicroAssay System (61137)

ANALYTE: Leucine Aminopeptidase (LAP) (3709)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)

ANALYTE: Lipase (3711)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT 60 (34016)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)

ANALYTE: Magnesium (4002)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Nova 8 (43022)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon Chem 1 Plus (61036)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Magnesium, Ionized (4018)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AVL 988-4 (04556)
    Nova Stat Profile Ultra 11P Analyzer (43101)

ANALYTE: Methemoglobin (4032)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ciba Corning 845 (10296)
    Ciba Corning 855 (10297)
    Ciba Corning 865 (10298)

ANALYTE: Microalbumin (4019)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim Hitachi 747 (07166)
    Boehringer Mannheim Hitachi 911 (07377)

ANALYTE: Microprotein, CSF (4026)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 CE (07491)
    Beckman Synchron CX 7 (07073)
    Boehringer Mannheim Hitachi 914 (07546)
    Olympus AU 5041 (46145)
    Olympus AU 800 (46110)

ANALYTE: Microprotein, Urine (4027)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 CE (07491)
    Beckman Synchron CX 7 (07073)
    Boehringer Mannheim Hitachi 914 (07546)
    Olympus AU 5041 (46145)
    Olympus AU 800 (46110)

ANALYTE: Myoglobin (4023)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Princeton BioMeditech AccuSign MI CK-MB/Myoglobin (49143)
    Princeton BioMeditech CarePoint MI CK-MB/Myoglobin (49141)
    Princeton BioMeditech LifeSign MI CK-MB/Myoglobin (49140)
    Princeton BioMeditech LifeSign MI Myoglobin (49122)
    Princeton BioMeditech VitalSign MI CK-MB/Myoglobin (49142)

ANALYTE: Osmolality, Serum (4602)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Instruments Model 3D3 Osmometer (04520)

ANALYTE: Osmolality, Urine (4603)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Instruments Model 3D3 Osmometer (04520)

ANALYTE: Oxyhemoglobin/Oxygen Saturation (4604)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ciba Corning 845 (10296)
    Ciba Corning 855 (10297)
    Ciba Corning 865 (10298)
    Radiometer ABL 620 (55137)

ANALYTE: Phosphorus (4906)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont ACA Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Potassium (4910)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AVL 988-4 (04556)
    American Monitor Parallel (04144)
    Beckman Synchron CX 3 Delta (07548)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Ciba Corning 850 (10251)
    Ciba Corning 855 (10297)
    Ciba Corning 860 (10269)
    Ciba Corning 865 (10298)
    Diametrics Medical IRMA Blood Analysis System (13362)
    Du Pont Dimension XL (13355)
    I-STAT i-STAT 200 System (28344)
    Instrumentation Laboratory Blood Gas 1630 (28337)
    Instrumentation Laboratory Blood Gas 1640 (28338)
    Instrumentation Laboratory Blood Gas 1650 (28339)
    Instrumentation Laboratory IL 1430 BGElectrolyte (28343)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Instrumentation Laboratory ILye Na, K, Cl System (28320)
    Instrumentation Laboratory ILye Na, K, Li System (28319)
    Ionetics Model 400/450 Electrolyte Analyzer (28324)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    Medica EasyLyte Calcium Analyzer (40197)
    Nova 10 (with CRT) (43061)
    Nova 16 (43103)
    Nova 8 (43022)
    Nova Stat Profile 9 (43086)
    Nova Stat Profile Plus 10 (43063)
    Nova Stat Profile Ultra 11P Analyzer (43101)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PDX Stat K Rapid Potassium Test System (49102)
    PrismaSystems PROCHEM (49105)
    Radiometer ABL 620 (55137)
    Radiometer EML 100 (55134)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    StatChem StatTest Sysem (58269)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Prealbumin (4911)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)

'ANALYTE: Prostatic Acid Phosphatase (PAP) (4918) [[Page 25958]] 
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Cirrus Diagnostics Immulite (10159)

ANALYTE: Prostatic Specific Antigen (PSA) (4919)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    TOSOH A1A-1200 (61040)

ANALYTE: Protein, Total (4921)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abaxis EPOC 2000 (04547)
    Abott Spectrum CCX (04515)
    Beckman Synchron CX 3 Delta (07548)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 CE (07491)
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Protein, Total (urine) (4972)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)
    Du Pont Dimension (13086)
    Du Pont Dimension AR (13087)
    Du Pont Dimension ES (13215)
    Du Pont Dimension XL (13355)

ANALYTE: Pseudocholinesterase (4923)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)

ANALYTE: Reduced Hemoglobin (5523)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ciba Corning 845 (10296)
    Ciba Corning 855 (10297)
    Ciba Corning 865 (10298)

ANALYTE: Retinol binding protein (5507)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)

ANALYTE: Sodium (5805)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AVL 988-4 (04556)
    Abbott Vision (04083)
    American Monitor Parallel (04144)
    Beckman Synchron CX 3 Delta (07548)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Ciba Corning 850 (10251)
    Ciba Corning 855 (10297)
    Ciba Corning 860 (10269)
    Ciba Corning 865 (10298)
    Diametrics Medical IRMA Blood Analysis System (13362)
    Du Pont Dimension XL (13355)
    I-STAT i-STAT 200 System (28344)
    Instrumentation Laboratory Blood Gas 1630 (28337)
    Instrumentation Laboratory Blood Gas 1640 (28338)
    Instrumentation Laboratory Blood Gas 1650 (28339)
    Instrumentation Laboratory IL 1430 BGElectrolyte (28343)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Instrumentation Laboratory ILyte Na, K, Cl System (28320)
    Instrumentation Laboratory ILyte Na, K, Li System (28319)
    Ionetics Model 400/450 Electrolyte Analyzer (28324)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    Medica EasyLyte Calcium Analyzer (40197)
    Nova 10 (with CRT) (43061)
    Nova 16 (43103)
    Nova 8 (43022)
    Nova Stat Profile 9 (43086)
    Nova Stat Profile Plus 10 (43063)
    Nova Stat Profile Ultra 11P Analyzer (43101)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    Radiometer ABL 620 (55137)
    Radiometer EML 100 (55134)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Total Solids (Protein) (6131)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    ATAGO A300CL Clinincal Refractometer (04575)
    ATAGO N Serum Protein Refractometer (04574)
    ATAGO SP-D Digital Serum Protein Refractometer (04579)
    ATAGO T-2 Clinical Refractometer (04577)
    National Instrument Hand Protometer (43085)

ANALYTE: Transferrin (6114)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Triglyceride (6118)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PrismaSystems Prochem (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Troponin T (Tn T) (6140)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim ES 300 (07160)

ANALYTE: Urea (BUN) (6403)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 3 Delta (07548)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    I-STAT i-STAT 200 System (28344)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Nova 16 (43103)
    Nova Stat Profile Plus 10 (43063)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Synermed IR 500 (58322)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Uric Acid (6404)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abaxis EPOC 2000 (04547)
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355) [[Page 25959]] 
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)
    PrismaSystems PROCHEM (49105)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Vitamin B12 (6707)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad RADIAS System (97493)
    Roche Cobas Mira Plus (55096)
    Sanofi Pasteur Access Immunoassay System (58257)
    Syva Vista Immunoassay System (58221)
    Technicon Immuno 1 System (61042)

SPECIALITY/SUBSPECIALITY: General Immunology

ANALYTE: Allergen specific IgE (0417)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Cirrus Diagnostic Immulite (10159)
    In Vitro Technologies Allergy Profile (28279)
    Sanofi Pasteur Access Immunoassay System (58257)

ANALYTE: Alpha-1 Microglobin (0470)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Array 360 (07052)
    Behring Nephelometer II (07563)

ANALYTE: Alpha-1-Acid Glycoprotein (orosomucoid) (0420)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)

Alpha-1-Antitrypsin (0421)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelomoter II (07563)

ANALYTE: Alpha-2 Macroglobulin (0422)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)

ANALYTE: Alpha-Fetoprotein--Tumor Marker (0424)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim ES 300 AL (07524)

ANALYTE: Anti-Nuclear Antibodies (ANA) (0441)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad Radias System (07493)
    J & S Medical Accutex SLE Latex Test (31002)

ANALYTE: Anti-Streptolysin O (ASO) (0452)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Behring Nephelometer II (07563)
    J & S Medical Accutex Antistreptolysin O (ASO) Latex Text 
(31006)

ANALYTE: Beta-2 microglobulin (0703)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Array 360 (07052)
    Cirrus Diagnostics Immulite (10159)
    Du Pont ACA Star (13357)
    Du Pont ACA V (13084)
    Wallac Oy AutoDELFIA (70167)

ANALYTE: C-Reactive Protein (CRP) (1001)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 747 (07166)
    Boehriner Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Immunostics immuno/crp Test (28277)
    J & S Medical Accutex C-Reactive Protein (CRP) Latex Text 
(31004)
    J & S Medical Eye Spot CRP test (31007)
    Pulse Scientific C-Reactive Protein (CRP) Test (49075)
    Technicon OPERA Clinical Chemistry System (61161 

ANALYTE: Complement C3 (1029)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 914 (07546)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Complement C4 (1030)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 914 (07546)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Cytomegalovirus Antibodies (1039)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    PB Diagnostics System OPUS (49001)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Vitek Systems Vidas (67038)

ANALYTE: Helicobacter Pylori Antibodies (2513)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Meridian Diagnostics ImmunoCard H. pylori (40195)
    SmithKline FlexSure HP Test (58321)

ANALYTE: Hemopexin (2517)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)

ANALYTE: Hepatitis A Virus Antibody (2519)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott IMX (04056)

ANALYTE: Immunoglobulins IgA (2803)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Immunoglobulins IgE (2805)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim ES 300 AL (07524)
    Cirrus Diagnostics Immulite (10159)
    Roche Cobas Core (55119)
    Sanofi Pasteur Access Immunoassay System (58257)
    Vitek Systems Vidas (67038)

ANALYTE: Immunoglobulins IgG (2806)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Immunoglobulins IgG subclasses (2807)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer (07273)
    Behring Nephelometer 100 (07272)

ANALYTE: Immunoglobulins IgM (2808)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Behring Nephelometer II (07563)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Infectious Mononucleosis Antibodies (Mono) (2809)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Immunostics immuno/im test (28278)
    J & S Medical Accutex Inf. Mono. Red Bld. Cell (IM RBC) Test 
(31003)
    J & S Medical Accutex Infectious Mononucleosis Latex Test 
(31008)
    J & S Medical Eye Spot Infectious Mononucleosis (IM) Test 
(31013)
    Meridian Diagnostics ImmunoCard Mono (40179)
    Pacific Biotech Concise Plus Mono (49148)
    Princeton BioMeditech BioSign Mono Test (49100)

ANALYTE: Kappa Light Chains (3402)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)

ANALYTE: Lambda Light Chains (3705)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)

ANALYTE: Mumps Antibodies (4007)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Vitek Systems Vidas (67038)

ANALYTE: Mycoplasma pneumoniae Antibodies (4016)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Meridian Diagnostics ImmunoCard Mycoplasma (40196)
    Murex Mycoplasma pneumoniae Antibody Detection Kit (40175)

ANALYTE: Rheumatoid Factor (RF) (5508)
    TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25960]] 
    Behring Nephelometer II (07563)
    Immunostics immuno/undiluted ra Test (28275)
    J & S Medical Accutex Rheumatoid Factor (RF) Latex Test (31005)
    J & S Medical Eye Spot Rheumatoid Factor (RF) Test (31012)
    Pulse Scientific Rheumatoid Factor (RF) Test (49101)
    Trinity Laboratories RHEUMA-LEX System (61116)

ANALYTE: Rickettsia typhi Ab (Typhus Antibodies) (5514)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Integrated Diagnostics INDX DIP-S-TICKS R. typhi (28265)

ANALYTE: Rubella Antibodies (5510)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Princeton BioMeditech BioSign Rubella (49121)
    Wampole IMPACT Rubella Slide Test (70165)

ANALYTE: Rubeola Antibodies (measles) (5511)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Vitek Systems Vidas (67038)

ANALYTE: Toxoplasma gondii Antibodies (6113)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biokit Toxogen (07494)
    PB Diagnostics Systems OPUS (49001)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Vitek Systems Vidas Toxo Competition (TXC) Assay (67080)

ANALTYE: Varicella-Zoster Virus Antibodies (6704)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Vitek Systems Vidas (67038)

SPECIALITY/SUBSPECIALITY: Hematology

ANALYTE: Activated Clotting Time (ACT) (0461)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    HemoTec Automated Coagulation Timer High Range Heparinase 
(25184)
    HemoTec Automated Coagulation Timer II (25180)
    HemoTec Automated Coagulation Timer II High Range Heparinase 
(25185)
    International Technidyne Hemochron 8000 (28298)
    International Technidyne Hemochron Jr. Microcoagulation (28345)

ANALYTE: Activated Partial Thromboplastin Time (APTT) (0409)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    American Bioproducts STA Analyzer (04594)
    Behring Fibrintimer A (07516)
    Cardiovascular Diagnostics TAS Analyzer (10257)
    Helena Laboratories Cascade M (25156)
    HemoTec Automated Coagulation Timer II (25180)
    Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
    International Technidyne Factor VI Premier (28296)
    International Technidyne Factor VI Premier SingleShot APTT 
(28293)
    International Technidyne Factor VI Premier Vacu-APTT (28295)
    International Technidyne Factor VI SingleShot APTT (28292)
    International Technidyne Factor VI Vacu-APTT (28294)
    International Technidyne Hemochron 400 Cit. One-Step APTT 
(28287)
    International Technidyne Hemochron 400 Direct Draw APTT (28282)
    International Technidyne Hemochron 401 Cit. One-Step APTT 
(28288)
    International Technidyne Hemochron 401 Direct Draw APTT (28283)
    International Technidyne Hemochron 800 Cit. One-Step APTT 
(28289)
    International Technidyne Hemochron 800 Direct Draw APTT (28284)
    International Technidyne Hemochron 8000 (28298)
    International Technidyne Hemochron 8000 Cit. One-Step APTT 
(28291)
    International Technidyne Hemochron 8000 Direct Draw APTT (28286)
    International Technidyne Hemochron 801 Cit. One-Step APTT 
(28290)
    International Technidyne Hemochron 801 Direct Draw APTT (28285)
    International Technidyne Microsample Coagulation Analyzer 
(28267)
    Medical Laboratory MLA Electra 1600C (40167)
    Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 
(46144)
    TOA Medical Electronics CA-1000 (61132)
    TOA Medical Electronics CA-5000 (61135)
    Vitek HEMOLAB (67075)

ANALYTE: Antithrombin III (ATIII) (0456)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)
    Du Pont ACA Star (13357)

ANALYTE: Body Fluid Microscopic Elements (0716)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    IRIS IRIScope Body Fld. Cell Count Sys. (RBC/WBC enum. only) 
(28333)

ANALYTE: Capillary fragility (1093)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Capillary Fragility/Tourniquet Test (10247)

ANALYTE: Fibrin Monomers (1927)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ethanol Gel; Protamine Sulfate (no serial dilutions) (16044)

ANALYTE: Fibrin Split Products (Fibrin Degradation) (1904)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Diagnostic Dimertest Latex Assay (07552)
    Baxter Diagnostic FDP Detection Set (07551)
    Du Pont ACA Star (13357)
    Organon Teknika AuraTek FDP (46153)
    Vitek FDP Slidex direct (67084)

ANALYTE: Fibrinogen (1905)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    American Bioproducts STA Analyzer (04594)
    Behring Nephelometer II (07563)
    Du Pont ACA Star (13357)
    Helena Laboratories Cascade M (25156)
    Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
    International Technidyne Factor VI (28093)
    International Technidyne Factor VI Premier (28296)
    International Technidyne Hemochron 400 (28094)
    International Technidyne Hemochron 401 (28095)
    International Technidyne Hemochron 800 (28096)
    International Technidyne Hemochron 8000 (28298)
    International Technidyne Hemochron 801 (28097)
    Medical Laboratory MLA Electra 1600C (40167)
    TOA Medical Electronics CA-1000 (61132)
    TOA Medical Electronics CA-5000 (61135)
    Vitek HEMOLAB (67075)

ANALYTE: Hematocrit (2514)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Cell-Dyn 1700 (04607)
    Abbott EnCounter (04525)
    Alicia Diagnostic Genesis I (04536)
    Coulter ONYX (10254)
    Coulter ONYX with Autoloader (10281)
    DMA H12 (13284)
    Danam Datacell 16CP (13363)
    Diametrics Medical IRMA Blood Analysis System (13362)
    I-STAT i-STAT 200 System (28344)
    Infolab I-1600 (28379)
    Instrumentation Laboratory BGElectrolytes (28063)
    Nova 16 (43103)
    Nova Stat Profile 9 (43086)
    Nova Stat Profile Plus 10 (43063)
    Nova Stat Profile Ultra 11P Analyzer (43101)
    Separation Technology STI HemataSTAT Model C70B (58310)
    Sysmex K-4500 (58358)
    Sysmex K-800 (58307)
    Sysmex SE-9000 (58318)
    Technalysis CELLEXIS Hematology Analyzer (61102)
    Technicon H.3 RTC System (61103)
    Technicon H. 3 RTX System (61104)
    Texas International Laboratories H12 (61128)

ANALYTE: Hemoglobin (2515)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AVL 995 Hb (04021)
    Abbott Cell-Dyn 1700 (04607)
    Abbott EnCounter (04525)
    Alicia Diagnostics Genesis I (04536)
    Artel HbM Hemoglobinometer (04551)
    Ciba Corning 280 (10036)
    Ciba Corning 288 (10037)
    Ciba Corning 845 (10296)
    Ciba Corning 855 (10297)
    Ciba Corning 865 (10298)
    Coulter ONYX (10254) [[Page 25961]] 
    Coulter ONYX with Autoloader (10281)
    DMA H12 (13284)
    Danam Datacell 16CP (13363)
    I-STAT i-STAT 200 System (28344)
    Infolab I-1600 (28379)
    Radiometer ABL 1 (55049)
    Radiometer ABL 2 (55001)
    Radiometer ABL 2 RA (55050)
    Radiometer ABL 3 (55002)
    Radiometer ABL 3 M (55051)
    Radiometer ABL 300 (55004)
    Radiometer ABL 4 (55006)
    Radiometer ABL 510 (55054)
    Radiometer ABL 520 (55055)
    Separation Technology STI HemataSTAT Model C70B (58310)
    StatChem StatTest System (58269)
    Sysmex K-4500 (58358)
    Sysmex K-800 (58307)
    Sysmex SE-9000 (58318)
    Technalysis CELLEXIS Hematology Analyzer (61102)
    Technicon H.3 RTC System (61103)
    Technicon H.3 RTX System (61104)
    Texas International Laboratories H12 (61128)

ANALYTE: Heparin (2518)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)

ANALYTE: Heparin Dose Response (HDR) (2539)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    International Technidyne Factor VI (28093)
    International Technidyne Hemochron 400 (28094)
    International Technidyne Hemochron 401 (28095)
    International Technidyne Hemochron 800 (28096)
    International Technidyne Hemochron 8000 (28298)
    International Technidyne Hemochron 801 (28097)

ANALYTE: Plasminogen (4907)

    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Nephelometer II (07563)
    Du Pont ACA Star (13357)

ANALYTE: Platelet Count (4908)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Cell-Dyn 1700 (04607)
    Abbott EnCounter (04525)
    Alicia Diagnostics Genesis I (04536)
    Coulter ONYX (10254)
    Coulter ONYX with Autoloader (10281)
    DMA H12 (13284)
    Danam Datacell 16CP (13363)
    Infolab I-1600 (28379)
    Sysmex K-4500 (58358)
    Sysmex K-800 (58307)
    Sysmex SE-9000 (58318)
    Technalysis CELLEXIS Hematology Analyzer (61102)
    Technicon H.3 RTC System (61103)
    Technicon H.3 RTX System (61104)
    Texas International Laboratories H12 (61128)

ANALYTE: Prothrombin Time (PT) (4922)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    American Bioproducts STA Analyzer (04594)
    Behring Fibrintimer A (07516)
    Boehringer Mannheim CoaguChek System (07496)
    Cardiovascular Diagnostics TAS Analyzer (10257)
    Helena Laboratories Cascade M (25156)
    HemoTec Automated Coagulation Timer II (25180)
    Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
    International Technidyne Factor VI Jr. Microcoagulation (28346)
    International Technidyne Factor VI Premier (28296)
    International Technidyne Hemochron 8000 (28298)
    International Technidyne Hemocrhon Jr. Microcoagulation (28345)
    Medical Laboratory MLA Electra 1600C (40167)
    Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 
(46144)
    TOA Medical Electronics CA-1000 (61132)
    TOA Medical Electronics CA-5000 (61135)
    Vitek HEMOLAB (67075)

ANALYTE: Red Blood Cell Count (Erythrocyte Count) (RBC) (5502)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Cell-Dyn 1700 (04607)
    Abbott EnCounter (04525)
    Alicia Diagnostics Genesis I (04536)
    Coulter ONYX (10254)
    Coulter ONYX with Autoloader (10281)
    DMA H12 (13284)
    Danam Datacell 16CP (13363)
    Infolab I-1600 (28379)
    Sysmex K-4500 (58358)
    Sysmex K-800 (58307)
    Sysmex SE-9000 (58318)
    Technalysis CELLEXIS Hematology Analyzer (61102)
    Technicon H.3 RTC System (61103)
    Technicon H.3 RTX System (61104)
    Texas International Laboratories H12 (61128)

ANALYTE: Reticulocyte Count (5506)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Becton Dickinson FACSCAN (with retic count software) (07518)
    Coulter MAXM (10078)
    Coulter STKS (10093)
    Technicon H.3 RTC System (61103)
    Technicon H.3 RTX System (61104)

ANALYTE: Semen (5822)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    IRIS IRIScope Body Fld. Cell Count Sys. (sperm enum. only) 
(28334)

ANALYTE: Thrombin Time (6105)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    American Bioproducts STA Analyzer (04594)
    Helena Laboratories Cascade M (25156)
    Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
    International Technidyne Factor VI Premier (28296)
    International Technidyne Factor VI Preimer Throm. Time Plus 
(28310)
    International Technidyne Factor VI Thrombin Time Plus (28309)
    International Technidyne Hemochron 400 HNTT (28299)
    International Technidyne Hemochron 400 HiTT (28304)
    International Technidyne Hemochron 401 HNTT (28300)
    International Technidyne Hemochron 401 HiTT (28305)
    International Technidyne Hemochron 800 HNTT (28301)
    International Technidyne Hemochron 800 HiTT (28306)
    International Technidyne Hemochron 8000 (28298)
    International Technidyne Hemochron 8000 HNTT (28303)
    International Technidyne Hemochron 8000 HiTT (28308)
    International Technidyne Hemochron 801 HNTT (28302)
    International Technidyne Hemochron 801 HiTT (28307)
    Medical Laboratory MLA Electra 1600C (40167)
    TOA Medical Electronics CA-1000 (61132)
    TOA Medical Electronics CA-5000 (61135)
    Vitek HEMOLAB (67075)

ANALYTE: White Blood Cell Count (Leukocyte Count) (WBC) (7002)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Cell-Dyn 1700 (04607)
    Abbott EnCounter (04525)
    Alicia Diagnostics Genesis I (04536)
    Coulter ONYX (10254)
    Coulter ONYX with Autoloader (10281)
    DMA H12 (13284)
    Danam Datacell 16CP (13363)
    Infolab I-1600 (28379)
    Sysmex K-4500 (58358)
    Sysmex K-800 (58307)
    Sysmex SE-9000 (58318)
    Technalysis CELLEXIS Hematology Analyzer (61102)
    Technicon H.3 RTC System (61103)
    Technicon H.3 RTX (61104)
    Texas International Laboratories H12 (61128)

ANALYTE: White Blood Cell Differential (WBC Diff) (7001)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Cell-Dyn 1700 (04607)
    Abbott EnCounter (04525)
    Alicia Diagnostics Genesis I (04536)
    Coulter ONYX (10254)
    Coulter ONYX with Autoloader (10281)
    DMA H12 (13284)
    Danam Datacell 16CP (13363)
    Infolab I-1600 (28379)
    Sysmex K-4500 (58358)
    Sysmex SE-9000 (58318)
    Technalysis CELLEXIS Hematology Analyzer (61102)
    Technicon H.3 RTC System (61103)
    Technicon H.3 RTX System (61104)
    Texas International Laboratories H12 (61128)

SPECIALITY/SUBSPECIALITY: Mycology

ANALYTE: Dermatophytes (1302)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Biomed Diagnostics InTray DM Medium (07559)
    Troy Biologicals Dermatophyte Test Medium (61106)

ANALYTE: Yeast, Candida only (7603) [[Page 25962]] 
    TEST SYSTEM, ASSAY OR EXAMINATION:
    MicroProbe Affirm VPIII Microbial Identification Test (40163)

SPECIALITY/SUBSPECIALITY: Parasitology

ANALYTE: Cryptosprodium (1109)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Alexon ProSpecT Cryptosporidum Rapid Assay (dir. Ag/vis.) 
(04553)

ANALYTE: Giardia lamblia (2222)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Alexon ProSpecT Giardia Rapid Assay (direct antigen/visual) 
(04364)

ANALYTE: Scabies (5831)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    All Direct Wet Mount Preparations (04108)

    ANALYTE: Trichomonas (6116)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    MicroProbe Affirm VPIII Microbial Identification Test (40163)

SPECIALITY/SUBSPECIALITY: Toxicology/TDM

    ANALYTE: Acetaminophen (0406)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)
    GDS Diagnostics Stat-Site Meter (22126)

    ANALYTE: Amikacin (0425)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)

ANALYTE: Amphetamines (0428)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt. 
(07528)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Drug Screening Systems microLINE Screens (13259)
    Du Pont ACA Star (13357)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Princeton BioMeditech AbuSign DOA 4 (49130)

ANALYTE: Barbiturates (0701)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt. 
(07528)
    Boehringer Mannheim Hitachi 914 (07546)
    Drug Screening Systems microLINE Screens (13259)
    Du Pont ACA Star (13357)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

ANALYTE: Benzodiazepines (0702)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt. 
(07528)
    Boehringer Mannheim Hitachi 914 (07546)
    Drug Screening Systems microLINE Screens (13259)
    Du Pont ACA Star (13357)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)

ANALYTE: Cannabinoids (THC) (1009)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt. 
(07528)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Princeton BioMeditech AbuSign DOA 4 (49130)
    Princeton BioMeditech AbuSign THC (49133)
    Princeton BioMeditech AccuSign THC (49139)
    Princeton BioMeditech BioSign THC (49137)
    Princeton BioMeditech DOA-COC (49135)
    Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)

ANALYTE: Carbamazepine (1010)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 1800 (28322)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS Magnum (49098)
    Seradyn LPIA-100 (58294)

ANALYTE: Carboxyhemoglobin (1012)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ciba Corning 845 (10296)
    Ciba Corning 855 (10297)
    Ciba Corning 865 (10298)
    Radiometer ABL 620 (55137)

ANALYTE: Cocaine Metabolites (1023)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt. 
(07528)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    EDITEK VERDICT COCAINE (16078)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Princeton BioMeditech AbuSign COC (49132)
    Princeton BioMeditech AbuSign DOA 4 (49130)
    Princeton BioMeditech AccuSign COC (49138)
    Princeton BioMeditech BioSign COC (49136)
    Princeton BioMeditech DOA-TCO (49134)
    Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

ANALYTE: Digitoxin (1303)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Cirrus Diagnostics Immulite (10159)
    Du Pont ACA Star (13357)

ANALYTE: Digoxin (1304)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Beckman Synchron CX 4 CE (07174)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim ES 300 AL (07524)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 250 (34037)
    Kodak Ektachem 950 IRC (34087)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Sanofi Pasteur Access Immunoassay System (58257)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)
    Vitek Systems Vidas (67038)
    Wako Diagnostics 30R (70002)

ANALYTE: Ethanol (Alcohol) (1608)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 950 IRC (34087)
    Olympus AU 5041 (46145)

ANALYTE: Ethosuximide (1609)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)

ANALYTE: Gentamicin (2202)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Seradyn LPIA-100 (58294)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Isonicotinic Acid (2819)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DynaGen MYCODYN URITEC Test Strips (13264)

ANALYTE: Lidocaine (3710)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)

ANALYTE: Lithium (3712)
    TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25963]] 
    Instrumentation Laboratory ILyte Na, K, Li System (28319)
    Ionetics Model 400/450 Electrolyte Analyzer (28324)
    Kodak Ektachem 250 (34037)
    Kodak Ektachem 400 (34012)
    Kodak Ektachem 500 (34013)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 (34014)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 700 P (34024)
    Kodak Ektachem 700 XR (34015)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT 60 (34016)
    Kodak Ektachem DT II (34057)
    Kodak Ektachem DT SC II Module (34028)
    Kodak Ektachem DT SC Module (34017)
    Kodak Ektachem DTE Module (34018)
    Nova 10 (with CRT) (43061)

ANALYTE: Methadone (4003)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biosite Triage Panel for Drugs of Abuse (07195)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA (13082)
    Du Pont ACA II (13172)
    Du Pont ACA III (13173)
    Du Pont ACA IV (13083)
    Du Pont ACA Star (13357)
    Du Pont ACA V (13084)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Roche Abuscreen ONTRAK (55099)

ANALYTE: Methamphetamines (4004)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt. 
(07528)

ANALYTE: Methaqualone (4005)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Boehringer Mannheim Hitachi 914 (07546)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)

ANALYTE: Methotrexate (4006)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)

ANALYTE: Morphine (4020)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Roche OnTrak TESTCUP Collection/Urinalysis Panel (55146)
    Sun Biomedical Labs Visualine II Morphine/Opiates/Heroin (58359)
ANALYTE: N-Acetylprocainamide (NAPA) (4301)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)
    PB Diagnostics Systems OPUS (49001)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)

ANALYTE: Opiates (4601)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidpresnt. 
(07528)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    EDITEK VERDICT OPIATES (16077)
    Olympus AU 5041 (46145)
    Olumpus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Princeton BioMeditech AbuSign DOA 4 (49130)
    Princeton BioMeditech AbuSign Opi (49144)
    Princeton BioMeditech AccuSign Opi (49146)
    Princeton BioMeditech BioSign Opi (49147)
    Princeton BioMeditech DOA-Opi (49145)

ANALYTE: Phencyclidine (PCP) (4901)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt. 
(07528)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    EDITEK EZ-Screen:PCP (16073)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)

ANALYTE: Phenobarbital (4902)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Baxter Paramax (07048)
    Baxter Paramax 720 (07186)
    Baxter Paramax 720 ZX (07049)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Seradyn LPIA-100 (58294)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Phenytoin (4903)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Baxter Paramax (07048)
    Baxter Paramax 720 (07186)
    Baxter Paramax 720 ZX (07049)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 250 (34037)
    Kodak Ektachem 950 IRC (34087)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Primidone (4912)
    TEST SYSTEM, ASSAY OR EXAMINATION
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)

ANALYTE: Procainamide (4913)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Du Pont ACA Star (13357)
    PB Diagnostics System OPUS (49001)

ANALYTE: Propoxyphene (4917)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)

ANALYTE: Quinidine (5202)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)

ANALYTE: Salicylates (5801)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 (IRC (34087)

ANALYTE: Theophylline (6104)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Baxter Paramax (07048)
    Baxter Paramax 720 (07186)
    Baxter Paramax 720 ZX (07049)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Immunomatrix Theophylline Blood Monitoring System (28318)
    Instrumentation Laboratory ILAB 1800 (28323)
    Instrumentation Laboratory ILAB 900 (28322)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    Kodak Ektachem DT II (34057)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Schiapparelli Biosystems ACE Clinical Chemistry System (58288)
    Technicon OPERA Clinical Chemistry System (61161)
    Vitek Systems Vidas (67038)

ANALYTE: Tobramycin (6112)
    TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25964]] 
    Abbott AxSYM (04532)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Tricyclic Antidepressants (6117)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Biosite Triage Panel Drugs of Abuse plus Tricyl.Antidprsnt. 
(07528)
    Du Pont ACA Star (13357)

ANALYTE: Valproic Acid (6701)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Boehringer Mannheim Hitachi 704 (07161)
    Boehringer Mannheim Hitachi 717 (07163)
    Boehringer Mannheim Hitachi 911 (07377)
    Boehringer Mannheim Hitachi 914 (07546)
    Ciba Corning Biotrack 516 (10048)
    Du Pont ACA Star (13357)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)
    Seradyn LPIA-100 (58294)

ANALYTE: Vancomycin (6703)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott AxSYM (04532)
    Du Pont ACA Star (13357)
    PB Diagnostics Systems OPUS (49001)
    PB Diagnostics Systems OPUS Magnum (49097)
    PB Diagnostics Systems OPUS PLUS (49098)

SPECIALITY/SUBSPECIALITY: Urinalysis

ANALYTE: Total Solids (Specific Gravity) (6125)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    ATAGO A300CL Clinical Refractometer (04575)
    ATAGO T-2 Clinical Refractometer (04577)
    ATAGO UG-1 Digital Urine Specific Gravity Refractometer (04576)
    ATAGO URICON-PN Urine Specific Gravity Refractometer (04578)
    Ames Clinitek Atlas Automated Urine Analyzer (04527)
    IRIS The Yellow IRIS Model 250 (28369)
    IRIS The Yellow IRIS Model 450 (28370)
    National Instrument Hand Protometer (43085)

ANALYTE: Urine Qualitative Dipstick Chemistries (6406)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ames Clinitek Atlas Automated Urine Analyzer (04527)
    Boehringer Mannheim CHEMSTRIP Mini UA Urine Analyzer (07565)
    Boehringer Mannheim Chemstrip Super UA Urine Analyzer (07520)

SPECIALITY/SUBSPECIALITY: Virology

ANALYTE: Adenovirus (0410)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Orion Diagnostica Diarlex Rota-Adeno (dir. antigen/visual) 
(46154)

ANALYTE: Rotavirus (5509)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott TestPack Rotavirus (direct antigen/visual) (04516)
    Meridian Diagnostics ImmunoCard Rotavirus (40189)
    Orion Diagnostica Diarlex Rota-Adeno (dir. antigen/visual) 
(46154)

COMPLEXITY: High

SPECIALITY/SUBSPECIALITY: Bacteriology

ANALYTE: Aerobic &/or Anaerobic Organisms-unlimited sources (0412)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Alamar Bacterial Identification Panel (including culture) 
(04531)
    Analytab API 20E/UniScept 20E (including culture) (04513)
    Becton Dickinson Crystal E/NF ID System (including culture) 
(07485)
    Becton Dickinson Crystal RS/E ID System (including culture) 
(07484)
    Micro Media Sys. Microdilution MIC/ID Panels (inc. culture) 
(40201)
    Radiometer Microbat 12A & 12A+12B G/neg ID Sys (inc. cult.) 
(55115)
    Roche Oxi/Ferm II (including culture) (55116)
    Vitek Systems Rapid NFT (including culture) (67076)

ANALYTE: Aerobic Organisms from urine specimens only (0468)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Adams Scientific Selecticult-U (nonconfirmatory ID) (04548)
    BioClinical Systems Bullseye Urine Plate (nonconfirm. ID) 
(07539)
    Culture Kits, Inc. Uri-Three (nonconfirmatory ID) (10262)
    Future Medical Tech. Intl. Qualture (nonconfirmatory ID) (19022)
    Innovative Diag. Systems IDS Rapid SS/U (including culture) 
(28053)
    Troy Biologicals Bacti-Star II Urine Sys. (nonconfirm. ID) 
(61142)
    Troy Biologicals Bacti-Star Urine Plate (nonconfirm. ID) (61143)
    Troy Biologicals Bacti-Urine Plate (nonconfirmatory ID) (61144)
    Troy Biologicals Uri-Check Plus (nonconfirmatory ID) (61145)
    UTI-tect Bacteriuria Diag. Test System (nonconfirmatory ID) 
(64028)

ANALYTE: Chlamydia (1016)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DAKO IDEIA Chlamydia (direct Ag/spectrophoto) (13329)
    DAKO IDEIA Chlamydia (direct Ag/visual) (13328)
    DAKO IMAGEN Chlamydia (direct antigen) (13334)
    Gen-Probe PACE 2C System (22171)
    Gen-Probe Pace2 Probe Competition Assay (PCA) (dir. Ag) (22166)
    NeoGenex C. trachomatis Antigen Test (direct antigen) (43099)
    NeoGenex C. trachomatis Antigen Test (inc. cell culture) (43098)
    Roche Amplicor Chlamydia Trachomatis Test (55118)
    Sanofi Pasteur Chlamydia Micro. EIA Blocking (dir.ag/spec.) 
(58330)
    Sanofi Pasteur Chlamydia Microplate EIA (dir. ag./spectro.) 
(58336)
    Syva MicroTrak II Chlamydia EIA Blocking Assay (dir.ag/spec) 
(58335)

ANALYTE: Clostridium difficile (1022)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Alexon ProSpecT Clostridium difficile (direct Ag/spectro) 
(04540)
    Alexon ProSpecT Clostridium difficile (direct Ag/visual) (04539)
    Becton Dickinson CULTURETTE BRAND Toxin CD (dir. Ag/visual) 
(07486)
    Becton Dickinson CULTURETTE BRAND Toxin CD (dir. Ag/Spectro) 
(07487)
    TechLab C. difficile 1-hour TOX-A Test (spectrophotometric) 
(61149)
    TechLab C. difficile 1-hour TOX-A Test (visual) (61148)
    TechLab C. difficile Toxin/Antitoxin Kit (61107)
    TechLab Clostridium difficile TOX-B Test (61147)

ANALYTE: Dental plaque (1317)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    BioScan Video Phase Contrast Microscope (07499)

ANALYTE: Escherichia coli (1604)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Remel E. coli 0157:H7 Latex Test (including culture) (55125)

ANALYTE: Legionella (3706)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Binax Legionella Urinary Antigen EIA (07527)

ANALYTE: N. gonorrhoeae (from urogenital or rectal only) (4317)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Gen-Probe PACE 2C System (22171)

ANALYTE: Neisseria gonorrhoeae (4302)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    E-Y Laboratories Gonochek-II Kit (16027)

ANALYTE: Salmonella (5802)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    SMI MED. Salmonella O Grouping (including culture) (58255)

ANALYTE: Staphyococcus (5807)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Trinity Laboratories STAPH-A-LEX System (including Culture) 
(61129)
    Unipath Staphytect-OD (including culture) (64030)

ANALYTE: Streptococcus pneumoniae (5808)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AB Biodisk Etest for S. pneumoniae (including culture) (04561)

ANALYTE: Streptococcus, group A (5810)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Becton Dickinson Precise STREP A (including culture) (07427)
    Gen-Probe Group A Streptococcus Direct Test 
(22165) [[Page 25965]] 
    Pro-lab Prolex Streptococcal Grouping Latex (inc. culture) 
(49116)
    Remel RIM Strep Grouping LA Test (including culture) (55139)
    Syntron QuikPac Strep A (EIA) Test (including culture) (58293)

ANALYTE: Streptococcus, group B (5811)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Pacific Biotech Cards O.S. Strep B. (including culture) (49115)
    Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture) 
(49116)
    Remel RIM Strep Grouping LA Test (including culture) (55139)

ANALYTE: Streptococcus, group C (5812)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture) 
(49116)
    Remel RIM Strep Grouping LA Test (including culture) (55139)

ANALYTE: Streptococcus, group D (5813)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture) 
(49116)

ANALYTE: Streptococcus, group F (5814)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture) 
(49116)
    Remel RIM Strep Grouping LA Test (including culture) (55139)

ANALYTE: Streptococcus, group G (5815)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Pro-Lab Prolex Streptococcal Grouping Latex (inc. culture) 
(49116)
    Remel RIM Strep Grouping LA Test (including culture) (55139)

SPECIALITY/SUBSPECIALITY: Endocrinology

ANALYTE: 17 OH Progesterone, Neonatal (0103)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Wallac Oy DELFIA Neo-17a-OHP Kit (70157)

ANALYTE: 17 alpha-OH Progesterone (0109)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Pantex NeoScreen ELISA 17 alpha-Hydroxyprogesterone (49124)

ANALYTE: 5-Hydroxyindolacetic Acid, Urine (5-HIAA) (0101)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    esa Coulochem Electrode Array System (CEAS) (16043)

ANALYTE: Adrenocorticotropic Hormone (ACTH) (0458)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence ACTH Assay (43074)

ANALYTE: Aldosterone (0459)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Diagnostic Systems DSL Active Aldosterone RIA Kit (13315)

ANALYTE: Catecholamines, Urine (1055)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bioanalytical Systems Urinary Catecholamine Kit (07560)

ANALYTE: Cortisol (1032)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence Cortisol Assay (43082)
    Wallac Oy DELFIA Cortisol Kit (70159)
    elias usa Synelisa Cortisol (16048)

ANALYTE: Cortisol, Urine (extraction procedure) (1095)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott TDX (04071)
    Abbott TDX FLx (04072)
    Sanofi Pasteur Access Immunoassay System (58257)
    Vitek Systems Vidas (67038)

ANALYTE: Dehydroepiandrosterone (DHEA) (1309)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Diagnositic Systems DSL-9000 Active DHEA RIA Kit (13309)
    Nichols Institute Chemiluminescence DHEA Assay (43079)
    elias usa Synelisa DHEA Sulfate EIA Kit (16062)

ANALYTE: Dehydroepiandrosterone Sulfate (DHEA-SO4) (1310)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence DHEA-S Assay (43083)

ANALYTE: Erythropoietin (1611)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Genzyme Predicta Erythropoietin Kit (22159)
    Nichols Institute Cheiluminescence Erythropoietin Assay (43100)
    R & D Systems Quantikine Erythropoietin ELISA (55114))
    R & D Systems Quantikine IVD Erythropoietin ELISA (55132)

ANALYTE: Estradiol (1605)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad CoTube (07138)
    Clinical Assays GammaCoat (10060)
    Diagnostic Products Corp. Coat-a-Count Estradiol-6 (13317)
    Wallac Oy DELFIA Estradiol Kit (70148)

ANALYTE: Estrone (1628)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Diagnostic Systems Estrone RIA Kit (13314)

ANALYTE: Follicle Stimulating Hormone (FSH) (1908)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence FSH Assay (43066)
    Roche Cobas Core FSH EIA (manual procedure) (55124)
    SeaLite Sciences AquaLite FSH (58342)
    Wallac Oy DELFIA hFSH Kit (70149)

ANALYTE: HCG, Beta, Serum, Quantitative (2502)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence HCG Assay (43081)
    SeaLite Sciences AquaLite hCG (58340)
    Wallac Oy DELFIA hCG Kit (70147)

ANALYTE: Homovanillic Acid (HVA) (2545)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    esa Coulochem Electrode Array System (CEAS) (16043)

ANALYTE: Human Growth Hormone (GH) (2547)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence HGH Assay (43068)
    Wallac Oy DELFIA hGH Kit (70162)

ANALYTE: Insulin-like Grwth Factor Bind. Protein3 (IGFBP-3) (2832)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Diagnostic Systems Active IGFBP-3 IRMA Kit (13375)
    Diagnostic Systems DSL-6700 IGFBP-3 RIA Kit (13310))
    Endocrine Sciences IGFBP-3 RIA Kit (16060)

ANALYTE: Luteinizing Hormone (LH) (3713)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    ICN ImmuChem LH-MW Elisa Kit (28269)
    Roche Cobas Core LH EIA (manual procedure) (55121)
    SeaLite Sciences AquaLite LH (58339)
    Wallac Oy DELFIA hLH Kit (70150)
    Wallac Oy DELFIA hLH Spec Kit (70151)

ANALYTE: Parathyroid Hormone--Intact (4924)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad CoTube (07138)
    Diagnostic Products Corp. Coat-A-Count (13030)
    Immunodiagnostic Systems ltd Gamma-BCT Intact PTH (28351)
    Immunodiagnostic Systems ltd OCTEIA Intact PTH (28350)
    Nichols Institute Chemiluminescence PTH Assay (43080)

ANALYTE: Progesterone (4914)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    CyberFluor FIAgen Progesterone Assay Kit (10261)
    Immunotech Progesterone RIA Kit (28325)
    Wallac Oy DELFIA Progesterone Kit (70153)
    elias usa Synelisa Progesterone (16046)

ANALYTE: Prolactin (4915)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott RIA Bead (04061)
    Nichols Institute Chemiluminescence Prolactin Assay (43069)
    Roche Cobas Core Prolactin EIA (manual procedure) (55122)
    Wallac Oy DELFIA Prolactin Kit (70152)

ANALYTE: Renin (5515)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute BV Active Renin RIA (43062)

ANALYTE: Sex Hormone Binding Globulin (5819)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Wallac Oy DELFIA SHBG Kit (70154)

ANALYTE: Testosterone (6102) [[Page 25966]] 
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Wallac Oy DELFIA Testosterone Kit (70155)

ANALYTE: Thyroid Stimulating Hormone (TSH) (6106)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence TSH Assay (43065)
    Roche Cobas Core TSH EIA (manual procedure) (55129)
    STC Diagnostics TSH Micro-Plate EIA (58308)
    SeaLite Sciences AquaLite TSH (58350)
    Wallac Oy DELFIA hTSH Kit (70142)

ANALYTE: Thyroid Stimulating Hormone (TSH) (Neonatal) (6107)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bioclone ELEGANCE Neonatal TSH ELISA (computer calculate) 
(07555)
    Bioclone ELEGANCE Neonatal TSH ELISA (manual calculations) 
(07554)
    Pantex NEOSCREEN ELISA TSH (49126)
    Wallac Oy DELFIA Neo-hTSH Kit (70156)

ANALYTE: Thyroxine (T4) (6109)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Tetrabead-125 (04519)
    Becton Dickinson SimulTRAC (07106)
    Nichols Institute Chemiluminescence Total T4 Assay (43070)
    Roche Cobas Core T4 EIA (manual procedure) (55131)
    Wallac Oy DELFIA T4 Kit (70145)

ANALYTE: Thyroxine Binding Globulin (TBG) (6110)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Wallac Oy DELFIA TBG Kit (70146)

ANALYTE: Thyroxine, Free (FT4) (6111)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Immunotech Free T4 RIA Kit (28326)
    Nichols Institute Chemiluminescence Free T4 Assay (43071)
    Roche Cobas Core FT4 EIA (manual procedure) (55128)
    STC Diagnostics Free T-4 Micro-Plate EIA (58289)
    Wallac Oy DELFIA Free T4 Kit (70143)

ANALYTE: Triiodothyronine (T3) (6119)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Monobind Coated Tube RIA Test System (40164)
    Nichols Institute Chemiluminescence Total T3 Assay (43072)
    Roche Cobas Core T3 EIA (manual procedure) (55130)
    Wallac Oy DELFIA T3 Kit (70144)

ANALYTE: Triiodothyronine Uptake (T3U) (TU) (6120)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence T3 Uptake Assay (43087)

ANALYTE: Triiodothyronine, Free (FT3) (6121)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence Free T3 Assay (43078)

ANALYTE: Vanillylmandelic Acid (VMA) (6710)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    esa Coulochem Electrode Array System (CEAS) (16043)
SPECIALITY/SUBSPECIALITY: General Chemistry

ANALYTE: 1-Methylhistidine (0107)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: 3-Methylhistidine (0108)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Alanine (0511)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Alanine Aminotransferase (ALT) (SGPT) (0404)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    STC Diagnostics ALT Micro-Plate Assay (58337)

ANALYTE: Albumin (0414)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Trace Scientific Albumin BCG Modified Reactivity (Manual) 
(61118)

ANALYTE: Alkaline Phosphatase (ALP) (0416)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Hybritech Tandem-R Ostase (25170)
    Synermed Test Kit (58260)

ANALYTE: Alpha-Amino-n-butyric Acid (0512)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Alpha-Aminoadipic Acid (0510)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Aminoethylcysteine (0513)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Ammonia, Plasma/Serum (0427)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bekman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Amylase (0429)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Genzyme Test Kit (22164)
    Intersect Systems Test Kit (28321)
    Pointe Scientific Manual Amylase Test (49103)
    Synermed Test Kit (58260)
    TECO Diagnostics Amylase Reagent Set (manual procedure) (61156)

ANALYTE: Angiotensin Converting Enzyme (ACE) (0481)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    ALPCO Angiotensin Converting Enzyme REA (04562)

ANALYTE: Anserine (0514)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Apolipoprotein A1 (0462)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence APO-A1 Assay (43077)

ANALYTE: Apolipoprotein B (0457)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence APO-B Assay (43073)

ANALYTE: Arginine (0515)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Asparagine (0509)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Aspartic Acid (0508)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Beta-Alanine (0732)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Beta-Aminoisobutyric Acid (0733)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Bilirubin, Direct (0704)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Horizon Direct Bilirubin Manual Procedure (25151)
    Synermed Test Kit (58260)

ANALYTE: Carbon Dioxide, Total (C02) (1003)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Intersect Systems Test Kit (28321)

ANALYTE: Carnosine (1108)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Cholesterol (1020)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    King Diagnostics Test Kit (34051)
    Randox Laboratories Test Kit (55106)

ANALYTE: Cholyglycine (Bile Acids) (1053)
    TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25967]] 
    Abbott CG RIA Kit (04517)

ANALYTE: Citrulline (1105)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Creatine Kinase (CK) 1034)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    King Diagnostics Test Kit (34051)
    Pointe Scientific Manual Creatine Kinase Test (49104)
    Randox Laboratories CK NAC-activated Test Kit (55117)
    Synermed Test Kit (58260)

ANALYTE: Creatine Kinase Isoenzymes (CK Isoenzymes) (1052)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Helena Laboratories REP E-Z CK-30 Isoenzyme Procedure (25153)

ANALYTE: Creatine Kinase MB Fraction (CKMB) (1002)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    CHEMROY Creatine Kinase-MB (CK-MB) Reagent Set (10280)
    Diagnostic Chemicals Ltd. Assay Kit (13210)
    Helena Laboratories Cardio REP CK Isoenzyme Procedure (25139)
    Helena Laboratories Cardio REP CK Isoforms Procedure (25140)
    Pointe Scientific Creatine Kinase-MB (manual procedure) (49117)

ANALYTE: Creatinine (1035)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Synermed Test Kit (58260)

ANALYTE: Cystathionine (1107)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Cystine (1106)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Ethanolamine (1629)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Ferritin (1902)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence Ferritin Assay (43067)
    Roche Cobas Core Ferritin EIA (manual procedure) (55123)
    Wallac Oy DELFIA Ferritin Kit (70161)

ANALYTE: Folate (Folic acid) (1907)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad Quantaphase II (07532)

ANALYTE: Gamma Glutamyl Transferase (GGT) (2201)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    King Diagnostics Test Kit (34051)
    Synermed Test Kit (58260)

ANALYTE: Gamma-Aminobutyric Acid (2220)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Glutamic Acid (2217)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Glutamine (2218)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Glycine (2219)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Glycosylated Hemoglobin (Hgb A1C) (2204)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    LSI ASCA Chemistry System (37069)
    Pointe Scientific Glycohemoglobin Test Kit (49114)
    Primus Rapid Gel Glycated Hemoglobin (49129)
    TECO Glycohemoglobin Kit (61141)

ANALYTE: HDL Cholesterol (2550)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    Intersect Systems Test Kit (28321)
    Olympus AU 5041 (46145)
    Olympus AU 5121 (46087)
    Olympus AU 5200 (46143)
    Technicon OPERA Clinical Chemistry System (61161)

ANALYTE: Hemoglobin C (2559)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Isolab HemoCard Hemoglobin C Assay (28340)

ANALYTE: Hemoglobin E (2556)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Isolab HemoCard Hemoglobin E (28268)

ANALYTE: Hemoglobin Fractions (2544)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Helena Laboratories REP Alkaline Hb-15 (25144)

ANALYTE: Hemoglobin S (2536)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad Variant (07498)
    Isolab Quik-Sep Quantitative Hemoglobin S Assay (28353)

ANALYTE: Histidine (2563)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Homocystine (2561)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Hydroxylysine (2562)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Hydroxyproline (2560)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Iron (2814)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    King Diagnostics Test Kit (34051)
    Sigma Diagnostics Test Kit (58051)

ANALYTE: Iron Binding Capacity (post saturation/separation) (2815)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott Spectrum CCX (04515)
    Beckman Synchron CX 5 CE (07491)
    Boehringer Mannheim Hitachi 914 (07546)
    Du Pont ACA Star (13357)
    Du Pont Dimension XL (13355)
    King Diagnostics Test Kit (34051)
    Kodak Ektachem 550 XRC Analyzer (34056)
    Kodak Ektachem 700 Analyzer C Series (34054)
    Kodak Ektachem 750 XRC Analyzer (34055)
    Kodak Ektachem 950 IRC (34087)
    LSI ASCA Chemistry System (37069)
    Olympus AU 5041 (46145)
    Olympus AU 5200 (46143)

ANALYTE: Iron Binding Capacity, Unsat. (UIBC) no pretreat. (2823)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Sigma Diagnostics Test Kit (58051)

ANALYTE: Isoleucine (2833)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Lactate Dehydrogenase (LDH) (3701)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    HiChem LDH/L Reagent Kit (manual) (25183)

ANALYTE: Lactate Dehydrogenase Isoenzymes (3721)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Helena Laboratories Cardio REP LD Isoenzyme Procedure (25169)

    ANALYTE: Leucine (3749)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Lipase (3711)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Meditech Diagnostic System Test Kit (40118)
    NuClin Diagnostics ElIpAse (43090)
    Sigma Diagnostics Lipase-PS (manual procedure) (58323)

    ANALYTE: Lipoprotein Fractions (3720)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Helena Laboratories REP Direct-Sep Cholesterol 
(25179) [[Page 25968]] 
    Helena Laboratories REP HDL/LDL-30 Electrophoresis System 
(25168)

    ANALYTE: Lysine (3750)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Magnesium (4002)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Horizon Diagnostics Magnesium (manual procedure) (25178)
    King Diagnostics Test Kit (34051)

    ANALYTE: Methionine (4031)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Microalbumin (4019)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Synermed IR 500 (58322)

    ANALYTE: Microprotein, CSF (4026)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DMA Test Kit (13216)
    Sterling Diagnostics Test Kit (58230)

    ANALYTE: Microprotein, Urine (4027)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DMA Test Kit (13216)
    Sterling Diagnostics Test Kit (58230)
    TRACE Scientific Test Kit (61044)

    ANALYTE: Ornithine (4606)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Phenylalanine (4942)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)
    ICN ImmuChem Phenylalanine Microwell Enzyme Assay (28384)
    Porton Cambridge Quantase Phenylalanine Assay (49125)

    ANALYTE: Phosphoethanolamine (4970)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Phosphoserine (4969)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Proline (4971)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Protein, Glycated (4963)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Diagnostic Specialties Protein-Bound Glucose Assay Kit (13286)

    ANALYTE: Protein, Total (4921)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    STC Diagnostics Total Protein Micro-Plate Assay (58347)

    ANALYTE: Proteolytic enzymes (4965)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Clinical Tech. Periocheck Enzyme Activity Kit (04526)

    ANALYTE: Sarcosine (5835)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Serine (5834)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Surfactant/Albumin Ratio (5833)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott TDX (04071)
    Abbott TDX FLx (04072)

    ANALYTE: Taurine (6141)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Threonine (6141)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Transferrin (6114)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    TRACE Scientific Test Kit (61044)

    ANALYTE: Triglyceride (6118)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Randox Laboratories Test Kit (55106)

    ANALYTE: Trypsin (6129)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    NuClin Diagnostics NuCliTryp RIA (43089)

    ANALYTE: Tryptophan (6144)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Tyrosine (6143)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Urea (BUN) (6403)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    AMRESCO BUN Reagent (manual procedure) (04554)
    Beckman System 6300 Series Amino Acid Analyzer (07553)

    ANALYTE: Uric Acid (6404)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Randox Laboratories Test Kit (55106)
    Synermed Test Kit (58260)

    ANALYTE: Valine (6717)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Beckman System 6300 Series Amino Acid Analyzer (07553)

ANALYTE: Vitamin B12 (6707)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Rad Quantaphase II (07532)

SPECIALITY/SUBSPECIALITY: General Immunology

ANALYTE: Allergen Specific NgE (0417)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ciba Corning Magic Lite SQ Specific IgE Immunoassay (10245)
    Hycor Biomedical Specific IgE EIA-TURBO (25146)
    Hycor Biomedical Specific IgE RIA Isotope Unit (25145)
    Hycor Ultra-EIA Specific IgE Assay (25166)
    MAST CLA Allergy System (densitometer) (40176)
    MAST CLA-1 Chemiluminescent Allergy System (40177)

ANALYTE: Alpha-1-Acid Glycoprotein (orosomucoid) (0420)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    The Binding Site BIND A RID Human Alpha-1 Acid Glycoprotein 
(61140)

ANALYTE: Anti-Arbovirus Antibodies (0498)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Hillcrest Biologicals Arbovirus (IgG) IFA Test (25141)
    Hillcrest Biologicals Arbovirus (IgM) IFA Test (25142)

ANALYTE: Anti-Cardiolipin Antibodies (0434)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Hemagen Cardiolipin Antibody Kit (25150)
    INOVA Diagnostics QUANTA Lite ACA Screen (28234)
    INOVA Diagnostics QUANTA Lite IgA ACA (28233)
    Immuno Concepts Anticardiolipin Ab Screening Test System (28280)
    Louisville APL Diagnostics ApHL ELISA Kit (37071)
    Shield Diagnostics DIASTAT Total Anti-Cardiolipin Kit (58295)
    elias usa Synelisa Cardiolipin Abs (IgA) (16055)
    elias usa Synelisa Cardiolipin Abs (IgG) (16056)
    elias usa Synelisa Cardiolipin Abs (IgM) (16057)
    elias usa elias Cardiolipin (IgA) Abs EIA (qualitative) (16066)
    elisa usa elias Cardiolipin (IgA) Abs EIA (semiquantitative) 
(16067)

ANALYTE: Anti-Centromere Antibodies (0487)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Shield Diagnostics DIASTAT Anti-Centromere Kit (58312)
    elias usa Synelisa ANA Profile (16058)
    elias usa Synelisa Centromere Abs (16047)
    elias usa Synelisa ENA Screen (qualitative) (16064)
    elias usa Synelisa ENA Screen (semiquantitative) (16065)
    elias usa Varelisa Centromere Antibodies (qualitative) (16085)
    elias usa Varelisa Centromere Antibodies (semi-quant.) (16086)

ANALYTE: Anti-DNA Antibodies (0435)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Cambridge Life Sciences AUTOZYME (10206) [[Page 25969]] 
    Cambridge Life Sciences AUTOZYME Screen (10263)
    Cambridge Life Sciences SELISA Anti-nDNA Ab Kit (10264)
    Clark Laboratories Encore dsDNA EIA Test (10238)
    Helix Diagnostics EIA Anti-dsDNA Test (25171)
    Immco Diagnostics Anti-dsDNA Antibody Test (28276)
    Immco Diagnostics Anti-native DNA Antibody Test (28312)
    Sigma Anti-dsDNA Kit (58346)
    The Binding Site BINDAZYME a-dsDNA EIA Kit (61112)
    The Binding Site Crithidia luciliae dsDNA Kit (61109)
    Zeus Autoantibody Profile-6 ELISA Test System (79042)
    elias usa Synelisa dsDNA Antibodies (16019)
    elias usa elias dsDNA Abs EIA Kit (16031)

ANALYTE: Anti-ENA Antibodies (0507)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    INOVA Diagnostics QUANTA Lite ENA 5 ELISA (28365)
    Shield Diagnostics DIASTAT ENA Single Well Screen Kit (58345)
    Zeus ENA Screen ELISA Test System (79044)

ANALYTE: Anti-Endomysial Antibodies (EMA) (0497)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Immco Diagnostics Anti-Endomysial Antibody (EMA) Test (28281)

ANALYTE: Anti-Histone Antibodies (0437)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    BioWhittaker RheumELISA II (07488)
    Cambridge Life Sciences AUTOZYME Screen (10263)
    INOVA Diagnostics QUANTA Lite Histone ELISA (28332)
    Immco Diagnostics ImmuLisa Anti-Histone Ab ELISA (28354)
    elias usa Synelisa Histone Antibodies EIA Kit (16041)

ANALYTE: Anti-Jo-1 (0438)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Biological Products ELISA-DOXA Combi-6 (04504)
    Advanced Biological Products ELISA-DOXA Jo-1 (04503)
    BioWhittaker RheumELISA II (07488)
    Cambridge Life Sciences AUTOZYME (10206)
    Hemagen ENA Screen 6 Kit (25160)
    Hemagen Jo-1 ENA Kit (qualitative) (25190)
    Hemagen Jo-1 ENA Kit (semi-quantitative) (25195)
    INOVA Diagnostics QUANTA Lite Jo-1 ELISA (28273)
    Immuno Concepts RELISA ENA Antibody Screening Test (28330)
    Molecular Immunodiagnostics Jo-1 EIA Test Kit (40182)
    The Binding Site ENA Screening CIE Kit (61114)
    Zeus ENA Profile-6 ELISA Test System (79045)
    elias usa Synelisa ANA Profile (16058)
    elias usa Synelisa ENA Screen (qualitative) (16064)
    elias usa Synelisa ENA Screen (semi-quantitative) (16065)
    elias usa Synelisa Jo-1 Antibodies EIA Kit (16038)
    elias usa Varelisa Jo-1 Antibodies (qualitative) (16081)
    elias usa Varelisa Jo-1 Antibodies (semi-quantitative) (16082)

ANALYTE: Anti-Mitochondrial Antibodies (AMTA) (0439)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    INOVA Diagnostics QUANTA Lite Mitochondria M2 ELISA (28270)
    Immco Diagnostics Autoantibody Test System (28311)
    elias usa Synelisa M2 Antibodies EIA Kit (16036)

ANALYTE: Anti-Myeloperoxidase (MPO) Antibodies (0505)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Shield Diagnostics DIASTAT Anti-MPO (qualitative) (58331)
    Shield Diagnostics DIASTAT Anti-MPO (semi-quantitative) (58332)

ANALYTE: Anti-Neutrophil Cytoplasm Antibodies (0440)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Shield Diagnostics DIASTAT Anti-PR3 (cANCA) (58329)

ANALYTE: Anti-Nuclear Antibodies (ANA) (0441)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    INOVA Diagnostics QUANTA Lite ENA 4 ELISA (28235)
    Immco Diagnostics Autoantibody Test System (28311)
    Immuno Concepts HEp-2000 Fluorescent ANA Test System (28366)
    Light Diag. ANA Test Kit with Mouse Liver Substrate (37097)
    Light Diag. ANA Test Kit with Rat Liver Substrate (37098)
    Shield Diagnostics Anti-Nuclear Antibody (ANA) Kit (58313)
    Tissue Culture Biotec ANA Test System (61108)
    Zeus ANA Screen ELISA (79043)
    elias usa ANA Total EIA Kit (16063)
    elias usa Synelisa ANA Total (16054)
    elias usa Synelisa ANA-8 Screen (16074)
    elias usa Varelisa ANA-8 Screen (16071)

ANALYTE: Anti-Parietal Cell Antibodies (0442)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Immco Diagnostics Autoantibody Test System (28311)
    elias usa Synelisa Parietal Cell Antibodies EIA Kit (16040)

ANALYTE: Anti-RNP (Ribonucleoprotein) (0443)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Biological Products ELISA-DOXA Combi-4 (04505)
    Advanced Biological Products ELISA-DOXA Combi-6 (04504)
    Advanced Biological Products ELISA-DOXA Sm/RNP Kit (04506)
    Apotex ANA Profile I (04507)
    Cambridge Life Sciences AUTOZYME (10206)
    Cambridge Life Sciences AUTOZYME Screen (10263)
    Clark Laboratories ENA Combined Test Kit (10255)
    Clark Laboratories Encore Sm/RNP Antigen EIA Test (10240)
    Helix Diagnostics EIA Extractable Nuclear Antigen Test (25157)
    Hemagen ENA Screen 6 Kit (25160)
    INOVA Diagnostics QUANTA Lite RNP ELISA (28236)
    Immco Diagnostics Anti-ENA Antibody Test (28317)
    Immco Diagnostics Anti-RNP and Anti-Sm Antibody Test (28314)
    Immunco Concepts RELISA ENA Antibody Screening Test (28330)
    Molecular Immunodiagnostics RNP EIA Test Kit (40184)
    The Binding Site ENA Screening CIE Kit (61114)
    Zeus Autoantibody Profile-6 ELISA Test System (79042)
    Zeus ENA Profile-6 ELISA Test System (79045)
    elias usa Synelisa ENA Screen (qualitative) (16064)
    elias usa Synelisa ENA Screen (semiquantitative) (16065)
    elias usa Synelisa Sm Abs/RNP-Sm Abs (16037)

ANALYTE: Anti-RNP-Sm Antibodies (0502)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Helix Diagnostics Anti-SM/RNP EIA Antibody Test (25165)
    elias usa Synelisa ANA Profile (16058)
    elias usa Varelisa RNP-Sm Antibodies (qualitative) (16079)
    elias usa Varelisa RNP-Sm Antibodies (semi-quantitative)(16080)

ANALYTE: Anti-Reticulin Antibodies (0444)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Immco Diagnostics Anti-Reticulin Antibody (ARA) Test (28331)

ANALYTE: Anti-SS-A/Ro (0446)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Biological Products ELISA-DOXA Combi-4 (04505)
    Advanced Biological Products ELISA-DOXA Combi-6 (04504)
    Advanced Biological Products ELISA-DOXA SSb Kit (04510)
    Apotex ANA Profile I (04507)
    Cambridge Life Sciences AUTOZYME (10206)
    Cambridge Life Sciences AUTOZYME Screen (10263)
    Clark Laboratories ENA Combined Test Kit (10255)
    Clark Laboratories Encore SS-A Antigen EIA Test (10241)
    Helix Diagnostics Anti-SS-A/Ro EIA Antibody Test (25148)
    Helix Diagnostics EIA Extractable Nuclear Antigen Test (25157)
    Hemagen ENA Screen 6 Kit (25160)
    Hemagen SS-A (Ro) ENA Kit (qualitative) (25187)
    Hemagen SS-A (Ro) ENA Kit (semi-quantitative) 
(25192) [[Page 25970]] 
    INOVA Diagnostics QUANTA Lite SS-A ELISA (28238)
    Immco Diagnostics Anti-ENA Antibody Test (28317)
    Immco Diagnostics Anti-SS-A(Ro) and Anti-SS-B(La) Test (28315)
    Immuno Concepts RELISA ENA Antibody Screening Test (28330)
    Molecular Immunodiagnostics Ro EIA Test Kit (40183)
    The Binding Site ENA Screening CIE Kit (61114)
    Zeus Autoantibody Profile-6 ELISA Test System (79042)
    Zeus ANA Profile-6 ELISA Test System (79045)
    elias usa Synelisa ANA Profile (16058)
    elias usa Synelisa ENA Screen (qualitative) (16064)
    elias usa Synelisa ENA Screen (semiquantitative) (16065)
    elias usa Synelisa Ro-Abs/La-Abs (16042)
    elias usa Varelisa SS-A/Ro Antibodies (qualitative) (16091)
    elias usa Varelisa SS-A/Ro Antibodies (semi-quantitative) 
(16092)

ANALYTE: Anti-SS-B/La (0447)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Biological Products ELISA-DOXA Combi-4 (04505)
    Advanced Biological Products ELISA-DOXA Combi-6 (04504)
    Advanced Biological Products ELISA-DOXA SSb Kit (04510)
    Apotex ANA Profile I (04507)
    Cambridge Life Sciences AUTOZYME (10206)
    Clark Laboratories ENA Combined Test Kit (10255)
    Clark Laboratories Encore SS-B Antigen EIA Test (10243)
    Helix Diagnostics Anti-SS-B/La EIA Antibody Test (25147)
    Helix Diagnostics EIA Extractable Nuclear Antigen Test (25157)
    Hemagen ENA Screen 6 Kit (25160)
    Hemagen SS-B (La) ENA Kit (qualitative) (25186)
    Hemagen SS-B (La) ENA Kit (semi-quantitative) (25191)
    INOVA Diagnostics QUANTA Lite SS-B ELISA (28239)
    Immco Diagnostics Anti-ENA Antibody Test (28317)
    Immco Diagnostics Anti-SS-A(Ro) and Anti-SS-B(La) Test (28315)
    Immuno Concepts RELISA ENA Antibody Screening Test (28330)
    Molecular Immunodiagnostics Ro EIA Test Kit (40186)
    The Binding Site ENA Screening CIE Kit (61114)
    Zeus Autoantibody Profile-6 ELISA Test System (79042)
    Zeus ANA Profile-6 ELISA Test System (79045)
    elias usa Synelisa ANA Profile (16058)
    elias usa Synelisa ENA Screen (qualitative) (16064)
    elias usa Synelisa ENA Screen (semiquantitative) (16065)
    elias usa Synelisa Ro-Abs/La-Abs (16042)
    elias usa Varelisa SS-B/Ro Antibodies (qualitative) (16089)
    elias usa Varelisa SS-B/Ro Antibodies (semi-quantitative) 
(16090)

ANALYTE: Anti-Sal-70 (0448)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Biological Products ELISA-DOXA Combi-6 (04504)
    Advanced Biological Products ELISA-DOXA Scl70 Kit (04511)
    BioWhittaker RheumELISA II (07488)
    Cambridge Life Sciences AUTOZYME (10206)
    Clark Laboratories ENA Combined Test Kit (10255)
    Hemagen ENA Screen 6 Kit (25160)
    Hemagen Scl-70 ENA Kit (qualitative) (25188)
    Hemagen Scl-70 ENA Kit (semi-quantitative) (25193)
    INOVA Diagnostics QUANTA Lite Scl-70 ELISA (28274)
    Immco Diagnostics Anti-Scl-70 Antibody Test (28316)
    Immuno Concepts RELISA ENA Antibody Screening Test (28330)
    Molecular Immunodiagnostics Scl-70 EIA Test Kit (40181)
    The Binding Site ENA Screening CIE Kit (61114)
    Zeus Autoantibody Profile-6 ELISA Test System (79042)
    Zeus ANA Profile-6 ELISA Test System (79045)
    elias usa Synelisa ANA Profile (16058)
    elias usa Synelisa ENA Screen (qualitative) (16064)
    elias usa Synelisa ENA Screen (semiquantitative) (16065)
    elias usa Synelisa Scl-70 Antibodies EIA Kit (16039)
    elias usa Varelisa Scl-70 Antibodies (qualitative) (16083)
    elias usa Varelisa Scl-70 Antibodies (semi-quantitative) (16084)

ANALYTE: Anti-Skin Antibodies (0449)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Immco Diagnostics Anti-Skin Antibody Test (28313)

ANALYTE: Anti-Sm (Smith) (0450)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Advanced Biological Products ELISA-DOXA Combi-4 (04505)
    Advanced Biological Products ELISA-DOXA Combi-6 (04504)
    Advanced Biological Products ELISA-DOXA Sm Kit (04509)
    Advanced Biological Products ELISA-DOXA Sm/RNP Kit (04506)
    Apotex ANA Profile I (04507)
    Cambridge Life Sciences AUTOZYME (10206)
    Cambridge Life Sciences AUTOZYME Screen (10263)
    Clark Laboratories ENA Combined Test Kit (10255)
    Clark Laboratories Encore Sm Antigen EIA Test (10244)
    Clark Laboratories Encore Sm/RNP Antigen EIA Test (10240)
    Helix Diagnostics EIA Anti-Sm Ab Test (25162)
    Helix Diagnostics EIA Extractable Nuclear Antigen Test (25157)
    Hemagen ENA Screen 6 Kit (25160)
    Hemagen Sm ENA Kit (qualitative) (25196)
    Hemagen Sm ENA Kit (semi-quantitative) (25197)
    INOVA Diagnostics QUANTA Lite SM ELISA (28237)
    Immco Diagnostics Anti-ENA Antibody Test (28317)
    Immco Diagnostics Anti-RNP and Anti-Sm Antibody Test (28314)
    Immuno Concepts RELISA ENA Antibody Screening Test (28330)
    Molecular Immunodiagnostics SM EIA Test Kit (40185)
    The Binding Site ENA Screening CIE Kit (61114)
    Zeus Autoantibody Profile-6 ELISA Test System (79042)
    Zeus ANA Profile-6 ELISA Test System (79045)
    elias usa Synelisa ANA Profile (16058)
    elias usa Synelisa ENA Screen (qualitative) (16064)
    elias usa Synelisa ENA Screen (semiquantitative) (16065)
    elias usa Synelisa Sm Abs/RNP-Sm Abs (16037)
    elias usa Varelisa Sm Antibodies (qualitative) (16087)
    elias usa Varelisa Sm Antibodies (semi-quantitative) (16088)

ANALYTE: Anti-Smooth Muscle Antibodies (ASMA) (0451)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Immco Diagnostics Autoantibody Test System (28311)

ANALYTE: Anti-Thyroglobulin Antibodies (0453)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Biomerica Anti-Thyroglobulin ELISA (07531)
    Clark Laboratories Encore Thyroglobulin EIA Test (10239)
    Cogent Diagnostics AUTOSTAT Autoantibody Test Kit (10207)
    Cogent Diagnostics AUTOSTAT II Autoantibody Test Kit (10267)
    INOVA Diagnostics QUANTA Lite Thyroid T ELISA (28271)
    Immunoprobe Thyroglobulin EIA Test Kit (28348)
    Joldon Diagnostics Thyroglobulin Auto Antibody EIA Kit (31010)
    Nichols Institute Chemiluminescence Anti-TG Assay (43075)
    elias usa Synelisa TG Abs/TPO Abs EIA Kit (16032)
    elias usa elias TGAb EIA Kit (16034)

ANALYTE: Anti-Thyroid Microsomal Antibodies (AMA) (0455)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Cogent Diagnostics AUTOSTAT Autoantibody Test Kit (10207)
    INOVA Diagnostics QUANTA Lite Thyroid M ELISA (28272)
    Immunoprobe Microsomal EIA Test Kit (28349)
    Joldon Diagnostics TMA Auto-Antibody EIA Kit (31009)
    Polymedco LUMItest anti-TPO (computer calculations) (49109)
    Polymedco LUMItest anti-TPO (manual calculations) 
(49110) [[Page 25971]] 
    elias usa elias TMAb EIA Kit (16035)

ANALYTE: Anti-Trypanosoma cruzi Antibodies (0503)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott COMMANDER System (04334)
    Abbott Chagas Antibody EIA (IgG) (04535)
    Gull Laboratories Chagas IgG ELISA (22173)

ANALYTE: Anti-U1-snRNP Antibodies (0501)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    elias usa Synelisa ANA Profile (16058)
    elias usa Synelisa ENA Screen (qualitative) (16064)
    elias usa Synelisa ENA Screen (semiquantitative) (16065)
    elias usa Synelisa U1-snRNP Antibodies EIA Kit (16033)

ANALYTE: B1 positive Lymphocytes (0735)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: B4 positive Lymphocytes (0736)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: Beta-2 microglobulin (0703)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Beta-2 Microglobulin EIA (10205)
    T Cell Diagnostics CELLFREE Beta-2 M Test Kit (61120)
    Wallac Oy DELFIA B-2 Micro Kit (70158)

ANALYTE: Blastomyces Antibodies (0724)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Meridian Diagnostics Premier Blastomyces EIA (40148)

ANALYTE: C-Reactive Protein (CRP) (1001)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Hemagen C-Relative Protein Kit (25172)

ANALYTE: CD3 (IgG1) positive Lymphocytes (1111)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: CD3 (IgG1)/B4 positive Lymphocytes (1112)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Epics Flow Cytometer (10246)

ANALYTE: CD3 (IgG1)/T4 positive Lymphocytes (1113)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Epics Flow Cytometer (10246)

ANALYTE: CD3 (IgG1)/T8 positive Lymphocytes (1114)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Epics Flow Cytometer (10246)

ANALYTE: CD3 positive Lymphocytes (1110)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Becton Dickinson FACSCount System (07601)

ANALYTE: CD3/HLA-DR positive Lymphocytes (1115)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Becton Dickinson FACScan Flow Cytometer (07497)

ANALYTE: CD4 positive Lymphocytes (1116)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter CD4 Cytospheres Kit (10248)

ANALYTE: CD4/CD3 positive Lymphocytes (1117)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Becton Dickinson FACSCount System (07601)

ANALYTE: CD8 positive Lymphocytes (1118)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter CD8 Cyto-Spheres Kit (10270)

ANALYTE: CD8/CD3 positive Lymphocytes (1119)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Becton Dickinson FACSCount System (07601)

ANALYTE: Coxiella burnetti (Q Fever) Antibodies (1067)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Hillcrest Biologicals Q Fever (IgG) IFA Test (25131)
    Hillcrest Biologicals Q Fever (IgM) IFA Test (25130)

ANALYTE: Cytomegalovirus Antibodies (1039)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott CMV-M EIA (04524)
    Baxter Bartels Cytomegalovirus IgG PRIMA System EIA (07502)
    Baxter Bartels Cytomegalovirus IgM PRIMA System EIA (07501)
    DAKO IDEIA CMV-M (13339)
    DAKO IDEIA CMV-M (13338)
    Zeus CMV ELISA (simultaneous IgM & IgG) Test System (79040)

ANALYTE: Epstein-Barr virus Antibodies (1603)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Epstein-Barr Virus IgG PRIMA System EIA (07504)
    Baxter Bartels Epstein-Barr Virus IgM PRIMA System EIA (07503)
    Fuller Laboratories EBV-EA IgG AB IFA Kit (19017)
    Fuller Laboratories EBV-EBNA IFA Kit (19018)
    Fuller Laboratories EBV-VCA IgG Ab IFA Kit (19016)
    Incstar Clin-ELISA EBV EA(D) IgG (28266)
    MRL Diagnostics Epstein-Barr Virus rVCA IgM (40194)
    Ortho Epstein-Barr Virus EA(D+R)-IgG Antibody ELISA Test (46146)
    Ortho Epstein-Barr Virus EBNA-IgG Antibody ELISA Test (46142)
    Virion EBV Combi Test (67085)
    Zeus EBV-VCA IgG Elisa (79039)

ANALYTE: Helicobacter pylori Antibodies (2513)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DAKO Helicobacter pylori IgG Test Kit (13342)
    Meridian Premier H. pylori EIA (spectrophotometric) (40199)
    Meridian Premier H. pylori EIA (visual) (40198)
    United Biotech UBI MAGIWEL H. pylori IgG Test (64025)

ANALYTE: Herpes simplex I and/or II Antibodies (2530)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Herpes simplex-1 Virus IgG PRIMA System EIA 
(07506)
    Baxter Bartels Herpes simplex-1 Virus IgM PRIMA System EIA 
(07505)
    Baxter Bartels Herpes simplex-2 Virus IgG PRIMA System EIA 
(07508)
    Baxter Bartels Herpes simplex-2 Virus IgM PRIMA System EIA 
(07507)

ANALYTE: Immunoglobulins--monoclonal/polyclonal (2802)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Helena Laboratories REP ImmunoFix (25133)
    Helena Laboratories Titan Gel Immunofix-9 Procedure (25149)
    The Binding Site IFE and Zone Electrophoresis Kit (61117)
    The Binding Site Immunofixation (IFE) Kit (61115)

ANALYTE: Immunoglobulins IgA (2803)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Crestat Diagnostics N-Assay TIA IgA (manual procedure) (10258)

ANALYTE: Immunoglobulins IgA subclasses (2827)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    The Binding Site Human IgA Subclasses NL RID Kit (61111)

ANALYTE: Immunoglobulins IgE (2805)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Abbott IgE EIA (04472)
    Diagnostics Products Corp. AlaTOP Microplate Allergy Screen 
(13293)
    Hycor HY-TEC Total IgE EIA (25161)
    MAST CLA Allergy System (densitometer) (40176)
    MAST CLA-1 Chemiluminescent Allergy System (40177)
    Roche Cobas Core IgE Total EIA (manual procedure) (55120)
    The Binding Site IgE EIA Test Kit (61105)
    Wallac Oy DELFIA Total IgE Kit (70163)

ANALYTE: Immunoglobulins IgG (2806)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Crestat Diagnostics N-Assay TIA IgG (manual procedure) (10256)

ANALYTE: Immunoglobulins IgG in tissue samples (2830)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ventana AEC Detection Kit (for tissue sample) (67081)
    Ventana DAB Detection Kit (for tissue sample) 
(67083) [[Page 25972]] 
    Ventana Red, Alk.Phos. Fast Red Detect. Kit (tissue sample) 
(67082)

ANALYTE: Immunoglobulins IgG subclasses (2807)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Research Diagnostics Human IgG Subclass RID Combi Kit (55151)
    Research Diagnostics IgG Subclass ELISA Combi Kit (55138)

ANALYTE: Immunoglobulins IgM (2808)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Crestat Diagnostics N-Assay TIA IgM (manual procedure) (10259)

ANALYTE: Immunoglobulins IgM in tissue samples (2831)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ventana AEC Detection Kit (for tissue sample) (67081)
    Ventana DAB Detection Kit (for tissue sample) (67083)
    Ventana Red, Alk.Phos. Fast Red Detect. Kit (tissue sample) 
(67082)

ANALYTE: Interleukin-2 Receptor (IL-2R) (2821)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    T Cell Diagnostics CELLFREE Interleukin-2 Receptor Kit (61119)

ANALYTE: Lyme Disease Antibodies (Borrelia burgdorferi Abs) (3714)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels B. burgdorferi (Lyme) IgM PRIMA System EIA 
(07509)

ANALYTE: MY4 positive Lymphocytes (4033)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: Mo2 positive Lymphocytes (4034)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: Mumps Antibodies (4007)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bion Mumps-G Antibody Test System (07480)

ANALYTE: Mycoplasma pneumoniae Antibodies (4016)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Fuller Laboratories Mycoplasma pneumoniae IgG Antibody Kit 
(19021)
    Shared Systems M. pneumoniae Antibody EIA Test System (58287)

ANALYTE: Rheumatoid Factor (RF) (5508)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Clark Laboratories Encore Rheumatoid Factor (RF) EIA Test 
(10242)
    Immco Diagnostics ImmuLisa Rheumatoid Factor ELISA (28352)
    Sigma Diagnostics Rheumatoid Factor IgM Kit (58333)
    TheraTest Laboratories EL-RF-IgM Kit (61134)

ANALYTE: Rubella Antibodies (5510)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Rubella Virus IgG PRIMA System EIA (07513)
    Baxter Bartels Rubella Virus IgM PRIMA System EIA (07512)
    DAKO IDEIA Rubella-G (13343)
    DAKO IDEIA Rubella-M (13344)

ANALYTE: Rubeola Antibodies (measles) (5511)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Rubeola Virus IgG PRIMA System EIA (07511)
    Baxter Bartels Rubeola Virus IgM PRIMA System EIA (07510)

ANALYTE: T1 positive Lymphocytes (6145)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: T11 positive Lymphocytes (6146)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)

ANALYTE: T11/B1 positive Lymphocytes (6147)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Epics Flow Cytometer (10246)

ANALYTE: T11/B4 positive Lymphocytes (6148)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Epics Flow Cytometer (10246)

ANALYTE: T3 positive Lymphocytes (6149)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: T4 positive Lymphocytes (6150)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: T4/T8 positive Lymphocytes (6151)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Epics Flow Cytometer (10246)

ANALYTE: T8 positive Lymphocytes (6152)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Coulter Clone Immunophenotyping by Fluorescence Microscopy 
(10253)
    Coulter Epics Flow Cytometer (10246)

ANALYTE: Thyroid Peroxidase Autoantibodies (TPO) (6135)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Nichols Institute Chemiluminescence Anti-TPO Assay (43076)
    elias usa Synelisa TG Abs/TPO Abs EIA Kit (16032)

ANALYTE: Toxoplasma gondii Antibodies (6113)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Toxo IgG PRIMA System EIA (07515)
    Baxter Bartels Toxo IgG PRIMA System EIA (07514)
    DAKO IDEIA Toxo-G (13340)
    DAKO IDEIA Toxo-M (13341)
    Zeus Toxo IgM Test System (79041)

SPECIALITY/SUBSPECIALITY: Hematology

ANALYTE: Activated Partial Thromboplastin Time (APTT) (0409)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Helena Laboratories APTT-ES (manual) (25158)
    MeDiTech APTT-ES (manual) (40192)
    Vitek HEMOLAB Silimat (manual) (67089)

ANALYTE: Activated Plasma Clotting Time (APCT) (0499)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    All Manual Tilt-Tube Coagulation Procedures (04424)

ANALYTE: Alpha-2-Antiplasmin (0463)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Medical Laboratory MLA Electra 1600C (40167)

ANALYTE: Antithrombin III (ATIII) (0456)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    American Bioproducts STA Analyzer (04594)
    Baxter Antithrombin III Chromogenic Assay (07535)
    Dade Thrombin-Antithrombin (TAT) Complex ELISA (13292)
    Kabi Pharmacia COATEST Antithrombin (manual) (34061)
    Medical Laboratory MLA Electra 1600C (40167)
    Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 
(46144)
    Sigma ACCUCOLOR Antithrombin III (58320)
    Vitek HEMOLAB (67075)

ANALYTE: Coagulation Factors (1044)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Diagnostica Stago Deficient II Factor Assay (manual) (13297)
    Diagnostica Stago Deficient V Factor Assay (manual) (13296)
    Diagnostica Stago Deficient VII Factor Assay (manual) (13305)
    Diagnostica Stago Deficient X Factor Assay (manual) (13306)
    Diagnostica Stago Deficient XI Factor Assay (manual) (13307)
    Diagnostica Stago Deficient XII Factor Assay (manual) (13304)
    Helena Laboratories Cascade M (25156)
    Instrumentation Laboratory MCL 2 Coagulation Analyzer (28297)
    International Technidyne Factor VI (28093)
    International Technidyne Factor VI Premier (28296)
    International Technidyne Hemochron 400 (28094)
    International Technidyne Hemochron 401 (28095)
    International Technidyne Hemochron 800 (28096) [[Page 25973]] 
    International Technidyne Hemochron 8000 (28298)
    International Technidyne Hemochron 801 (28097)
    MeDiTech Chromogenic Factor VIII:C Assay Kit (40180)
    Medical Laboratory MLA Electra 1600C (40167)
    Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 
(46144)
    TOA Medical Electronics CA-1000 (61132)
    TOA Medical Electronics CA-5000 (61135)
    Vitek HEMOLAB (67075)

ANALYTE: Fibrin Monomers (1927)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Protamine Sulfate (with serial dilutions) (49106)

ANALYTE: Fibrinogen (1905)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    All Manual Tilt-Tube Coagulation Procedures (04424)
    Behring Multifibren U (manual) (07545)
    Behring Multifibrin (manual) (07517)
    Diagnostic Specialties EnZIP Immunoturbidometric (manual) 
(13319)
    Helena Laboratories Fibrinogen Assay Kit (manual) (25152)
    The Binding Site Human Fibrinogen RID (61101)

ANALYTE: Hematocrit (2514)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DMA H10 (13283)
    DMA H3-HCT (13277)
    DMA H5 (13280)
    DMA H5-M (13279)
    DMA H7 (13281)
    Mallinckrodt H5-M (40171)
    Mallinckrodt S-610 (40169)
    Mallinckrodt S-650 (40172)
    Mallinckrodt S-670 (40173)
    SmithKline ESKALAB-CHS H10 (58305)
    SmithKline ESKALAB-CHS H3-HCT (58300)
    SmithKline ESKALAB-CHS H5 (58303)
    SmithKline ESKALAB-CHS H5-M (58302)
    SmithKline ESKALAB-CHS H7 (58304)
    Texas International Laboratories H10 (61127)
    Texas International Laboratories H3-HCT (61121)
    Texas International Laboratories H5 (61124)
    Texas International Laboratories H5-M (61123)
    Texas International Laboratories H7 (61125)

ANALYTE: Hemoglobin (2515)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DMA H10 (13283)
    DMA H3-Hgb (13278)
    DMA H5 (13280)
    DMA H5-M (13279)
    DMA H7 (13281)
    Mallinckrodt H5-M (40171)
    Mallinckrodt S-630 (40170)
    Mallinckrodt S-650 (40172)
    Mallinckrodt S-670 (40173)
    SmithKline ESKALAB-CHS H10 (58305)
    SmithKline ESKALAB-CHS H3-Hgb (58301)
    SmithKline ESKALAB-CHS H5 (58303)
    SmithKline ESKALAB-CHS H5-M (58302)
    SmithKline ESKALAB-CHS H7 (58304)
    Texas International Laboratories H10 (61127)
    Texas International Laboratories H3-Hgb (61122)
    Texas International Laboratories H5 (61124)
    Texas International Laboratories H5-M (61123)
    Texas International Laboratories H7 (61125)

ANALYTE: Heparin (2518)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Berichrome Heparin (07481)
    Biopool Spectrolyse Heparin (07526)
    Vitek HEMOLAB (67075)
    Vitek HEMOLAB Heparichrom (67095)

ANALYTE: Heparin, Low Molecular Weight (LMWH) (2558)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Instrumentation Laboratory IL Test Heparin (Xa) (28341)

ANALYTE: Heparin/Protamine Titration (HPT) (2538)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    International Technidyne Factor VI (28093)
    International Technidyne Hemochron 400 (28094)
    International Technidyne Hemochron 401 (28095)
    International Technidyne Hemochron 800 (28096)
    International Technidyne Hemochron 801 (28097)

ANALYTE: Lupus Anticoagulants (3728)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    American Diagnostica DVVtest &DVVconfirm (manual) (04543)
    Biopool Bioclot LA (manual procedure) (07522)
    Diagnostica Stago STACLOT LA (13285)
    Diagnostica Stago STACLOT PNP (13273)

    Gradipore Lupo-Test II & Lucor (22163)
ANALYTE: Plasminogen (4907)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    American Bioproducts STA Analyzer (04594)
    Medical Laboratory MLA Electra 1600C (40167)
    The Binding Site Plasminogen RID Test Kit (61159)

ANALYTE: Plasminogen Activator Inhibitor (PAI) (4936)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Plasminogen Activator Inhibitor-1 (PAI) (07521)
    Biopool Spectrolyse/pL PAI (07482)

ANALYTE: Platelet Count (4908)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DMA H10 (13283)
    DMA Plt-4 (13282)
    Mallinckrodt Plt-4 (40174)
    SmithKline ESKALAB-CHS H10 (58305)
    SmithKline ESKALAB-CHS Plt-4 (58306)
    Texas International Laboratories H10 (61127)
    Texas International Laboratories Plt-4 (61126)

ANALYTE: Protamine Response Test (PRT) (4945)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    International Technidyne Hemochron 8000 (28298)

ANALYTE: Protein C (4929)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Fibrintimer A (07516)
    Boehringer Mannheim Hitachi 704 (07161)
    Boehringer Mannheim Hitachi 705 (07162)
    Boehringer Mannheim Hitachi 717 (07163)
    Chromogenix COAMATE Protein C (manual procedure) (10252)
    Medical Laboratory MLA Electra 1600C (40167)
    Organon Teknika Multi Channel Discrete Analyzer (MDA-180) 
(46144)
    Roche Cobas Bio (55100)
    Roche Cobas FARA (55040)
    Roche Cobas Mira (55044)
    The Binding Site Human Protein C RID Test Kit (61180)
    Vitek HEMOLAB (67075)
    Vitek HEMOLAB Protein C chrom (manual procedure) (67086)

ANALYTE: Protein S (4930)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Instrumentation Laboratory IL ACL 100 (28073)
    Instrumentation Laboratory IL ACL 1000 (28074)
    Instrumentation Laboratory IL ACL 200 (28075)
    Instrumentation Laboratory IL ACL 2000 (28076)
    Instrumentation Laboratory IL ACL 300 (28077)
    Instrumentation Laboratory IL ACL 300 Plus (28197)
    Instrumentation Laboratory IL ACL 3000 (28078)
    Instrumentation Laboratory IL ACL 3000 Plus (28079)
    Instrumentation Laboratory IL ACL 810 (28080)

ANALYTE: Prothrombin Time (PT) (4922)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Helena Laboratories Thromboplastin Reagent-MI (manual) (25163)

ANALYTE: Red Blood Cell Count (Erythrocyte Count) (RBC) (5502)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DMA H10 (13283)
    DMA H3-HCT (13277)
    DMA H3-Hgb (13278)
    DMA H5 (13280)
    DMA H5-M (13279)
    DMA H7 (13281)
    Mallinckrodt H5-M (40171)
    Mallinckrodt S-610 (40169)
    Mallinckrodt S-630 (40170)
    Mallinckrodt S-650 (40172)
    Mallinckrodt S-670 (40173)
    SmithKline ESKALAB-CHS H10 (58305)
    SmithKline ESKALAB-CHS H3-HCT (58300)
    SmithKline ESKALAB-CHS H3-Hgb (58301) [[Page 25974]] 
    SmithKline ESKALAB-CHS H5 (58303)
    SmithKline ESKALAB-CHS H5-M (58302)
    SmithKline ESKALAB-CHS H7 (58304)
    Texas International Laboratories H10 (61127)
    Texas International Laboratories H3-HCT (61121)
    Texas International Laboratories H3-Hgb (61122)
    Texas International Laboratories H5 (61124)
    Texas International Laboratories H5-M (61123)
    Texas International Laboratories H7 (61125)
ANALYTE: Reptilase Time (5521)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Batroxobin (manual procedure) (07534)

ANALYTE: Reticulocyte Count (5506)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Becton Dickinson FACScan Flow Cytometer (07497)

ANALYTE: Semen (5822)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Serono Penetrak (58352)

ANALYTE: Thrombin Time (6105)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Test Thrombin (manual) (07495)
    Vitek HEMOLAB Thrombicalci-Test (manual) (67090)

ANALYTE: Thrombin/antithrombin III Complex (TAT) (6136)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Behring Enzygnost TAT (07483)

ANALYTE: Tissue Plasminogen Activator (t-PA) (6130)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Biopool TintElize tPA (07525)

ANALYTE: White Blood Cell Count (Leukocyte Count) (WBC) (7002)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DMA H10 (13283)
    DMA H3-HCT (13277)
    DMA H3-Hgb (13278)
    DMA H5 (13280)
    DMA H5-M (13279)
    DMA H7 (13281)
    Mallinckrodt H5-M (40171)
    Mallinckrodt S-610 (40169)
    Mallinckrodt S-630 (40170)
    Mallinckrodt S-650 (40172)
    Mallinckrodt S-670 (40173)
    SmithKline ESKALAB-CHS H10 (58305)
    SmithKline ESKALAB-CHS H3-HCT (58300)
    SmithKline ESKALAB-CHS H3-Hgb (58301)
    SmithKline ESKALAB-CHS H5 (58303)
    SmithKline ESKALAB-CHS H5-M (58302)
    SmithKline ESKALAB-CHS H7 (58304)
    Texas International Laboratories H10 (61127)
    Texas International Laboratories H3-HCT (61121)
    Texas International Laboratories H3-Hgb (61122)
    Texas International Laboratories H5 (61124)
    Texas International Laboratories H5-M (61123)
    Texas International Laboratories H7 (61125)

ANALYTE: von Willebrand Factor (Ristocetin Cofactor) (6711)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Chrono-log Ristocetin Cofactor Assay (10282)

SPECIALITY/SUBSPECIALITY: Mycology

ANALYTE: Yeast (7601)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Innovative Diag. Systems RapID Yeast Plus System (inc. cult) 
(28383)

ANALYTE: Yeast, Cryptocococcus only (7604)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Trinity Laboratories CRYPTO-LEX System (61136)

SPECIALITY/SUBSPECIALITY: Parasitology

ANALYTE: Cryptosporidium (1109)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Alexon ProSpecT Cryptosporidium Microtiter (dir Ag/spectro) 
(04326)
    Alexon ProSpecT Cryptosporidium Microtiter (dir Ag/visual) 
(04325)
    LMD Laboratories Cryptosporidium Ag Detect. Microtiter(vis) 
(37018)
    Meridian Diagnostics MERIFLUOR Cryptosporidium (40100)
    Meridian Diagnostics MERIFLUOR Cryptosporidium/Giardia (40095)
    Seradyn Color Vue--Cryptosporidium (dir. Ag/spectrophoto) 
(58184)
    Seradyn Color Vue--Cryptosporidium (direct, Ag/visual) (58297)

ANALYTE: Entamoeba histolytica (1631)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Alexon ProSpecT Entamoeba histolytica (direct Ag/spectro) 
(04530)
    Alexon ProSpecT Entamoeba histolytica (direct Ag/visual) (04529)

ANALYTE: Giardia lamblia (2222)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Alexon ProSpecT Giardia EZ Microplate Assay (dir Ag/spectr) 
(04585)
    Alexon ProSpecT Giardia EZ Microplate Assay (dir Ag/visual) 
(04586)
    Alexon ProSpecT Giardia Microplate Assay (dir Ag/spectro) 
(04557)
    Alexon ProSpecT Giardia Microplate Assay (dir Ag/visual) (04558)
    Alexon ProSpecT Giardia Microtiter (dir Ag/spectrophoto) (04257)
    Alexon ProSpecT Giardia Microtiter (dir antigen/visual) (04099)
    Alexon ProSpecT/Giardia (tube) (dir Ag/visual) (04338)
    Antibodies Inc. Giard EIA (direct antigen/visual) (04224)
    LMD Laboratories G. lamblia Ag Detect. Microtiter (spectro) 
(37032)
    LMD Laboratories G. lamblia Ag Detect. Microtiter (visual) 
(37019)
    Meridian Diagnostics MERIFLUOR Cryptosporidium/Giardia (40095)
    Meridian Diagnostics MERIFLUOR Giardia (40099)
    Seradyn Color Vue--Giardia (dir Ag/spectrophoto) (58183)
    Seradyn Color Vue--Giardia (direct Ag/visual) (58296)
    Trend Scientific Giardia lamblia Direct Detection System (61019)

ANALYTE: Pneumocystis (4926)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Polysciences Fungi-Fluor Pneumocystis (49099)

SPECIALITY/SUBSPECIALITY: Toxicology/TDM

ANALYTE: Amphetamines (0428)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Microdiagnostics MICRO EIA (40191)
    STC Diagnostics Amphetamines EIA Plate Kit (58299)
    USDT Flow Immunoassay System (64026)

ANALYTE: Cannabinoids (THC) (1009)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    STC Diagnostics Cannabinoids EIA Plate Kit (58292)
    USDT Flow Immunoassay System (64026)

ANALYTE: Cocaine Metabolites (1023)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    USDT Flow Immunoassay System (64026)

ANALYTE: Digoxin (1304)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Diatron FAST Test System (13287)
    Wallac Oy DELFIA Digoxin Kit (70160)

ANALYTE: Morphine (4020)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Immunalysis Urine Morphine Direct RIA Kit (28342)

ANALYTE: Opioates (4601)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Microdiagnostics Micro EIA Opiate Metabolites (40168)
    STC Diagnostics Opiates EIA Plate Kit (58298)
    USDT Flow Immunoassay System (64026)

ANALYTE: Phencyclidine (PCP) (4901)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    USDT Flow Immunoassay System (64026)

SPECIALITY/SUBSPECIALITY: Virology

ANALYTE: Adenovirus (0410)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Viral Respiratory Kit (including cell cult) 
(07359)
    Light Diag. Respir. Panel 1 Screen & ID Kit (inc. cell cult) 
(37068)

ANALYTE: Cytomegalovirus (1038)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Diagnostic Products PathoDx Cytomegalovirus (inc. cell cult) 
(13298)
    Light Diag. Cytomegalovirus Indirect Immunofluorescence Kit 
(37089)
    NeoGenex CMV Early Antigen Test (including cell culture) (43092)

ANALYTE: Herpes simplex (2529)
    TEST SYSTEM, ASSAY OR EXAMINATION: [[Page 25975]] 
    DAKO IDEIA Herpes simplex (direct Ag) (13332)
    DAKO IMAGEN Herpes simplex (inc. cell culture) (13333)

ANALYTE: Human Papillomavirus (HPV) (2540)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Digene ViraType Plus HPV DNA Assay (13323)

ANALYTE: Influenza A (2828)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Analytab API IMAGEN Influenza Virus A&B (direct antigen) (04215)
    Analytab API IMAGEN Influenza Virus A&B (inc.cell culture) 
(04512)
    Baxter Bartels PRIMA Influenza A EIA (direct Ag/spectro) (07490)
    Baxter Bartels PRIMA Influenza A EIA (inc. cell culture) (07492)
    Baxter Bartels Viral Respiratory Kit (direct antigen) (07035)
    Baxter Bartels Viral Respiratory Kit (including cell cult) 
(07359)
    DAKO IMAGEN Influenza (direct antigen) (13336)
    DAKO IMAGEN Influenza (including cell culture) (13337)
    Gull Laboratories Influenza A Test (including cell culture) 
(22106)
    Light Diag. Respir. Panel 1 Screen & ID Kit (inc.cell cult) 
(37068)
    NeoGenex Influenza A Antigen Test (including cell culture) 
(40393)

ANALYTE: Influenza B (2829)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Analytab API IMAGEN Influenza Virus A&B (direct antigen) (04215)
    Analytab API IMAGEN Influenza Virus A&B (inc. cell culture) 
(04512)
    Baxter Bartels Viral Respiratory Kit (direct antigen) (07035)
    Baxter Bartels Viral Respiratory Kit (including cell cult) 
(07359)
    DAKO Diagnostics IMAGEN Influenza (direct antigen) (13336)
    DAKO Diagnostics IMAGEN Influenza (including cell culture) 
(13337)
    Gull Laboratories Influenza B Test (including cell culture) 
(22107)
    Light Diag. Respir. Panel 1 Screen & ID Kit (inc. cell cult) 
(37068)
    NeoGenex Influenza B Antigen Test (including cell culture) 
(43096)

ANALYTE: Parainfluenza 1 (4959)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Viral Respiratory Kit (direct antigen) (07035)
    Baxter Bartels Viral Respiratory Kit (including cell cult) 
(07359)
    DAKO IMAGEN Parainfluenza virus Group (inc. cell culture) 
(13373)
    DAKO IMAGEN Parainfluenza virus Types 1, 2, 3 (inc. cell cult) 
(13374)
    Light Diag. Respir. Panel 1 Screen & ID Kit (inc.cell cult) 
(37068)
    Symex ViraSTAT Anti-Parainfluenza MAbs (58315)

ANALYTE: Parainfluenza 2 (4960)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Viral Respiratory Kit (including cell cult) 
(07359)
    DAKO IMAGEN Parainfluenza virus Group (inc. cell culture) 
(13373)
    DAKO IMAGEN Parainfluenza virus Types 1,2,3 (inc. cell cult) 
(13374)
    Light Diag. Respir. Panel 1 Screen & ID Kit (inc. cell cult) 
(37068)
    Symex ViraSTAT Anti-Parainfluenza MAbs (58315)

ANALYTE: Parainfluenza 3 (4961)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Viral Respiratory Kit (direct antigen) (07035)
    Baxter Bartels Viral Respiratory Kit (including cell cult) 
(07359)
    DAKO IMAGEN Parainfluenza virus Group (inc. cell culture) 
(13373)
    DAKO IMAGEN Parainfluenza virus Types 1,2,3 (inc. cell cult) 
(13374)
    Light Diag. Respir. Panel 1 Screen & ID Kit (inc. cell cult) 
(37068)
    Symex ViraSTAT Anti-Parainfluenza MAbs (58315)

ANALYTE: Respiratory syncytial virus (5503)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Baxter Bartels Viral Respiratory Kit (direct antigen) (07035)
    Baxter Bartels Viral Respiratory Kit (including cell cult) 
(07359)
    DAKO IMAGEN RSV (direct antigen) (13335)
    Diagnostic Products Corp. PathoDx RSV Kit (direct antigen) 
(13324)
    Diagnostic Products Corp. PathoDx RSV Kit (inc. cell cult.) 
(13325)
    Light Diag. Respir. Panel 1 Screen & ID Kit (inc. cell cult) 
(37068)
    NeoGenex RSV Antigen Test (including cell culture) (43094)
    Sanofi/Kallestad RSV Microplate EIA (direct Ag/spectro) (58286)

ANALYTE: Rotavirus (5509)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    DAKO ELISA Rotavirus Kit (direct Ag/spectrophoto) (13331)
    DAKO ELISA Rotavirus Kit (direct Ag/visual) (13330)
    DAKO IDEIA Rotavirus (direct antigen/spectro) (13295)
    DAKO IDEIA Rotavirus (direct antigen/visual) (13294)

ANALYTE: Varicella-Zoster viruses (6705)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Viro Varicella-Zoster Virus ID Reagent (direct antigen) (67093)
    Viro Varicella-Zoster Virus ID Reagent (inc. cell culture) 
(67094)

COMPLEXITY: WAIVED

SPECIALITY/SUBSPECIALITY: Endocrinology

ANALYTE: Ovulation Test (LH) by Visual Color Comparison (9461)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Applied Biotech Ovugen 1-Step Ovulation Prediction Test (04514)
    BioGenex OvuGen 1-Step Ovulation Prediction Test (07477)
    Disease Detection Internat. Pro-Step LH Ovulation Pred. Tst 
(13316)
    Princeton BioMeditech OvuSign One-Step Ovulation Prediction 
(49093)
    TCPI One Step LH Test (61158)

ANALYTE: Urine HCG by Visual Color Comparison Tests (9642)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    ANI BIOCARD HCG (04549)
    ANI BIOTECH OY BIOCARD HCG (04502)
    Abbott TestPack HCG-combo (04074)
    Advanced Care Products 1 Easy Step ADVANCE Pregnancy Test 
(04591)
    Apotex ProPhase Plus (04534)
    Apotex ProStrip HCG (04533)
    Apothecus VCF One Step Pregnancy Test (04606)
    Applied Biotech SureStep Combo hCG (04528)
    Applied Biotech SureStep HCG Pregnancy Test (04441)
    Applied Biotech SureStick HCG Pregnancy Test (04522)
    Becton Dickinson Precise One-step Pregnancy Test (07476)
    BioTech Atlantic UniStep HCG Pregnancy Test Device (07544)
    BioTech Atlantic UniStep HCG Pregnancy Test Strips (07543)
    Biomed Diagnostics ProClinic One-Step DipStick Pregnancy (07478)
    Boehringer Mannheim BMIt EVATEST Test Strip (07550)
    Boehringer Mannheim EVENT test strip hCG (07533)
    Disease Detection International Pro-Step PT hCG (13271)
    Disease Detection International Pro-Step hCG (13270)
    Eucardio Laboratories UC QIK 1-Step HCG Test (16072)
    Eucardio Laboratory UC Qik Pregnancy Test (16029)
    King's Bay Prelude hCG Combo Kit (34062)
    Mainline Technology MAINLINE Confirms hCG (40190)
    Medix Biotech BESTest hCG Urine (40166)
    Mizuho USA HCG Midstream (40178)
    Organon Teknika Predictor Pregnancy Test (46151)
    Pacific Biotech Concise Plus HCG-Urine (49123)
    Princeton BioMeditech BioStrip hCG (49131)
    Princeton BioMeditech LifeSign 1 One-Step Home Preg. Test 
(49127)
    Princeton BioMeditech LifeSign Plus One Step Home Pregnancy 
(49095)
    Quidel Conceive 1-Step Pregnancy Test (52021)
    Quidel QuickVue One-Step hCG Combo Test (52022)
    Quidel QuickVue One-Step hCG Test (52018)
    Quidel RapidVue hCG (52025)
    SA Scientific Pregnancy Check (58328)
    SA Scientific SAS One-Step Pregnancy (58282)
    SA Scientific SAS Pregnancy Strip (58284)
    SA Scientific SAS Serum/Urine hCG (58283)
    Stanbio QuPid Plus hCG Pregnancy Test (58326)
    Stanbio QuPid visual one-step pregnancy test (58325)
    Stanbio QuStick visual one-step pregnancy test (58324)
    Sun Biomedical Laboratories Visualine II HCG 
(58341) [[Page 25976]] 
    Syntron Bioresearch Be Sure Plus One Step Pregnancy Test (58285)
    Syntron Bioresearch QuikPac II hCG Combo Kit (58353)
    TCPI PDQ (Pregnancy Detected Quickly) Wand (61166)
    TCPI hCG Pregnancy One Step Test Strip (61100)
    TCPI hCG Pregnancy One Step Wand (61167)
    TECH-CO Visual HCG Pregnancy Test (61099)
    TECO One-Step Pregnancy Test (61146)
    The Mentholatum Co. BODYWISE Pregnancy Test (61160)
    True Medix Beta Spec hCG (61139)
    Unipath Clearview HCG DUO (64031)
    Unipath Clearview HCG Test (64024)

SPECIALITY/SUBSPECIALITY: General Chemistry

ANALYTE: Fecal Occult Blood (9191)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Aerscher HemaPrompt (04544)
    Propper Super Seracult (49096)

ANALYTE: Glucose Monitoring Devices (FDA Cleared/Home Use) (9221)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Ames Glucometer ELITE Blood Glucose Test Strips (04521)
    Ames Glucometer ELITE Diabetes Care System (04499)
    Ames Glucometer ENCORE Blood Glucose Test Strips (04501)
    Ames Glucometer ENCORE QA Blood Glucose Meter (04423)
    Ames Glucometer ENCORE System (04500)
    Ames Glucometer QA Blood Glucose Meter (04422)
    Boehringer Mannheim Accu-Chek Advantage (07523)
    Cascade Medical CheckMate Plus Blood Glucose System (10236)
    Clinical Diagnostics GLUCOchek Visual Test Strips (10272)
    Diagnostic Solutions Quick Check One Bld Glucose Test Strips 
(13300)
    Diagnostic Solutions Relief Plus Blood Glucose Test Strips 
(13299)
    HemoCue B-Glucose System (25112)
    Home Diagnostics ULTRA+ Blood Glucose Reagent Strips (25154)
    Lifescan ONE TOUCH IIB Blood Glucose Meter (37067)
    Polymer Technology ``655'' Glucose Test Strips (49094)

SPECIALITY/SUBSPECIALITY: Hematology

ANALYTE: Spun Microhematocrit (9581)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Separation Technology STI HemataSTAT II (58311)
    Separation Technology STI HemataSTAT Model C70 (58309)

SPECIALITY/SUBSPECIALITY: Urinalysis

ANALYTE: Urine Dipstick or Tablet Analytes, nonautomated (9641)
    TEST SYSTEM, ASSAY OR EXAMINATION:
    Bio-Scan Bio-Gen 2 (07456)
    Bio-Scan Bio-Gen 3 (07455)
    Bio-Scan Bio-Gen 4 (07454)
    Bio-Scan Bio-Gen 5 (07453)
    Bio-Scan Bio-Gen 6 (07452)
    Bio-Scan Bio-Gen 7 (07451)
    Bio-Scan Bio-Gen 8 (07450)
    Bio-Scan Bio-Glu Ketone (07457)
    Bio-Scan Bio-Glucose (07459)
    Bio-Scan Bio-Ketone (07458)
    BioScan Reagent Strips (07541)
    Boehringer Mannheim Chemstrip 10 S-UA (07519)
    Eiken UROPAPER Eiken 5 (16049)
    Eiken UROPAPER Eiken 6B (16059)
    Eiken UROPAPER Eiken 7 (16053)
    Eiken UROPAPER Eiken 8 (16052)
    Eiken UROPAPER Eiken AG (16050)
    Eiken UROPAPER Eiken GK(16068)
    Eiken UROPAPER Eiken GP (16069)
    Eiken UROPAPER Eiken HAG (16051)
    Eli Lilly Tes-Tape (Glucose Enzymatic Test Strip) (16030)
    TECO Diagnostics Urine Reagent Strips 3 (61153)

[FR Doc. 95-11653 Filed 5-12-95; 8:45 am]
BILLING CODE 4160-17-M