+-----------------------------------------------------------------------+
| ## Anti-HIV-1 Assays                                                  |
|                                                                       |
|   ---------------------------------------------------------- -----    |
| -------- ------------- -------------- ------------------ ------------ |
|   **Tradename(s)**                                           **F      |
| ormat**    **Sample**    **Use**        **Manufacturer**   **Approval |
|                                                                       |
|                                                                Date** |
|                                                                       |
|   HIVAB HIV-1 EIA                                            E        |
| IA           Serum /       Donor Screen   Abbott             3/1/1985 |
|                                                                       |
|                      Plasma                       Laboratories\       |
|                                                                       |
|                                                   Abbott Park, IL\    |
|                                                                       |
|                                                   US License 0043     |
|                                                                       |
|   [Genetic Systems rLAV                                      EI       |
| A           Serum /       Donor Screen   Bio-Rad            6/29/1998 |
|   EIA](http://www.fda.gov/cber/products/hiv1gen062998.                |
| htm)                 Plasma                       Laboratories Blood  |
|                                                                       |
|                                                   Virus Division\     |
|                                                                       |
|                                                   Redmond, WA\        |
|                                                                       |
|                                                   US License 1109     |
|                                                                       |
|   Murex SUDS HIV-1 Test                                      Ra       |
| pid EIA     Serum /       Donor Screen   Murex Diagnostics, 5/22/1992 |
|                                                                       |
|                      Plasma                       Inc.\               |
|                                                                       |
|                                                   Norcross, GA\       |
|                                                                       |
|                                                   US License 1152     |
|                                                                       |
|   Vironostika HIV-1 Microelisa System                        EIA      |
|            Serum /       Donor Screen   bioMerieux, Inc.\  12/18/1987 |
|                                                                       |
|                      Plasma                       100 Rodolphe        |
|                                                                       |
|                                                   Street\             |
|                                                                       |
|                                                   Durham, NC 27712\   |
|                                                                       |
|                                                   US License 1624     |
|                                                                       |
|   [Vironostika HIV-1 Plus O Microelisa                       E        |
| IA           Plasma /      Diagnostic,    bioMerieux, Inc.\  6/6/2003 |
|   System](http://www.fda.gov/cber/pma/P020066.htm)                    |
|                      Serum / Dried Non-Donor      100 Rodolphe        |
|                                                                       |
|                      Blood Spots   Screen         Street\             |
|                                                                       |
|                                                   Durham, NC 27712\   |
|                                                                       |
|                                                   US License 1624     |
|                                                                       |
|   Cambridge Biotech HIV-1 Western Blot Kit                   W        |
| B            Serum /       Donor          Calypte Biomedical 1/3/1991 |
|                                                                       |
|                      Plasma        Supplemental   Corp.\              |
|                                                                       |
|                                                   Berkeley, CA\       |
|                                                                       |
|                                                   US License 1207     |
|                                                                       |
|   Genetic Systems HIV-1 Western Blot                         WB       |
|            Serum /       Donor          Bio-Rad            11/13/1998 |
|                                                                       |
|                      Plasma        Supplemental   Laboratories Blood  |
|                                                                       |
|                                                   Virus Division      |
|                                                                       |
|   Fluorognost HIV-1 IFA                                      I        |
| FA           Serum /       Donor          Waldheim           2/5/1992 |
|                                                                       |
|                      Plasma        Supplemental   Pharmazeutika       |
|                                                                       |
|                                                   G.m.b.H.\           |
|                                                                       |
|                                                   Vienna, Austria\    |
|                                                                       |
|                                                   US License 1150     |
|                                                                       |
|   HIVAB HIV-1 EIA                                            EI       |
| A           Dried Blood   Non-Donor      Abbott             4/22/1992 |
|                                                                       |
|                      Spot          Screen         Laboratories        |
|                                                                       |
|   HIV-1 Urine EIA                                            E        |
| IA           Urine Screen  Non-Donor      Calypte Biomedical 8/6/1996 |
|                                                                       |
|                                    Screen         Corp.               |
|                                                                       |
|   [Genetic Systems rLAV                                      EI       |
| A           Dried Blood   Non-Donor      Bio-Rad            6/29/1998 |
|   EIA](http://www.fda.gov/cber/products/hiv1gen062998.                |
| htm)                 Spot          Screen         Laboratories Blood  |
|                                                                       |
|                                                   Virus Division      |
|                                                                       |
|   Vironostika HIV-1 Microelisa System                        EI       |
| A           Dried Blood   Non-Donor      bioMerieux, Inc.\  4/11/1990 |
|                                                                       |
|                      Spot          Screen         100 Rodolphe        |
|                                                                       |
|                                                   Street\             |
|                                                                       |
|                                                   Durham, NC 27712    |
|                                                                       |
|   Oral Fluid Vironostika HIV-1 Microelisa System             EIA      |
|            Oral Fluid    Non-Donor      bioMerieux, Inc.\  12/23/1994 |
|                                                                       |
|                                    Screen         100 Rodolphe        |
|                                                                       |
|                                                   Street\             |
|                                                                       |
|                                                   Durham, NC 27712    |
|                                                                       |
|   [Cambridge Biotech HIV-1 Western Blot                      WB       |
|             Urine         Non-Donor      Calypte Biomedical 5/28/1998 |
|   Kit](http://www.fda.gov/cber/products/hiv1cam052898.                |
| htm)                               Supplemental   Corp.               |
|                                                                       |
|   Genetic Systems HIV-1 Western Blot                         WB       |
|            Dried Blood   Non-Donor      Bio-Rad            11/13/1998 |
|                                                                       |
|                      Spot          Supplemental   Laboratories Blood  |
|                                                                       |
|                                                   Virus Division      |
|                                                                       |
|   [OraSure HIV-1 Western Blot                                W        |
| B            Oral Fluid    Non-Donor      Epitope, Inc.      6/3/1996 |
|   Kit](http://www.fda.gov/cber/pma/P950004.htm)                       |
|                                    Supplemental                       |
|                                                                       |
|   Fluorognost HIV-1 IFA                                      IF       |
| A           Dried Blood   Non-Donor      Waldheim           5/14/1996 |
|                                                                       |
|                      Spot          Supplemental   Pharmazeutika       |
|                                                                       |
|                                                   G.m.b.H.            |
|                                                                       |
|   [OraQuick Rapid HIV-1 Antibody                             Ra       |
| pid EIA     Fingerstick   Non-Donor      OraSure            11/7/2002 |
|   Test](http://www.fda.gov/cber/pma/P010047.htm)                      |
|                                    Screen         Technologies,       |
|                                                                       |
|                                                   Inc.\               |
|                                                                       |
|                                                   150 Webster         |
|                                                                       |
|                                                   Street\             |
|                                                                       |
|                                                   Bethlehem, PA       |
|                                                                       |
|                                                   18015-1389          |
|                                                                       |
|   Reveal Rapid HIV-1 Antibody Test                           Ra       |
| pid         Serum /       Non-Donor      MedMira            4/16/2003 |
|                                                                       |
|        Immunoassay   Plasma        Screen         Laboratories,       |
|                                                                       |
|                                                   Inc.\               |
|                                                                       |
|                                                   Halifax, Nova       |
|                                                                       |
|                                                   Scotia\             |
|                                                                       |
|                                                   Canada B3S 1B3      |
|   ---------------------------------------------------------- -----    |
| -------- ------------- -------------- ------------------ ------------ |
|                                                                       |
| ##                                                                    |
|                                                                       |
| ##                                                                    |
|                                                                       |
| ##                                                                    |
|                                                                       |
| ##                                                                    |
|                                                                       |
| ##                                                                    |
|                                                                       |
| ##                                                                    |
|                                                                       |
| ## Anti-HIV-1/2 Assays                                                |
|                                                                       |
| +---------+------+---------+----------+-----------------+------+      |
| | **      | **   | **S     | **Use**  | *               | **   |      |
| | Tradena | Form | ample** |          | *Manufacturer** | Appr |      |
| | me(s)** | at** |         |          |                 | oval |      |
| |         |      |         |          |                 | Da   |      |
| |         |      |         |          |                 | te** |      |
| +---------+------+---------+----------+-----------------+------+      |
| | Abbott  | EIA  | Serum / | Donor    | Abbott          | 2    |      |
| | HIVAB   |      | Plasma  | Screen   | Laboratories\   | /14/ |      |
| | HIV-    |      |         |          | Abbott Park,    | 1992 |      |
| | 1/HIV-2 |      |         |          | IL\             |      |      |
| | (rDNA)  |      |         |          | US License 0043 |      |      |
| | EIA     |      |         |          |                 |      |      |
| +---------+------+---------+----------+-----------------+------+      |
| | Genetic | EIA  | Serum / | Donor    | Bio-Rad         | 1    |      |
| | Systems |      | Plasma  | Screen   | Laboratories    | 2/9/ |      |
| | HIV-    |      | /       |          | Blood Virus     | 2000 |      |
| | 1/HIV-2 |      | Ca      |          | Division\       |      |      |
| | Peptide |      | daveric |          | Redmond, WA\    |      |      |
| | EIA     |      | Serum   |          | US License 1109 |      |      |
| +---------+------+---------+----------+-----------------+------+      |
| | Genetic | EIA  | Serum   | Donor    | Bio-Rad         | 8/5/ |      |
| | Systems |      | /Plasma | Screen   | Laboratories,   | 2003 |      |
| | HIV-    |      |         |          | Inc\            |      |      |
| | 1/HIV-2 |      |         |          | 4000 Alfred     |      |      |
| | *PLUS*  |      |         |          | Nobel Drive\    |      |      |
| | O EIA   |      |         |          | Hercules, CA    |      |      |
| |         |      |         |          | 94547\          |      |      |
| |         |      |         |          | License 1109    |      |      |
| |         |      |         |          |                 |      |      |
| |         |      |         |          |                 |      |      |
| +---------+------+---------+----------+-----------------+------+      |
|                                                                       |
| ## Anti-HIV-2 Assay                                                   |
|                                                                       |
|   ------------------ -                                                |
| ----------- ------------ ------------ ------------------ ------------ |
|   **Tradename(s)**                                                    |
|  **Format**   **Sample**   **Use**      **Manufacturer**   **Approval |
|                                                                       |
|                                                                Date** |
|                                                                       |
|   Genetic Systems                                                     |
|   EIA          Serum /      Donor Screen Bio-Rad            4/25/1990 |
|   HIV-2 EI                                                            |
| A                       Plasma                    Laboratories Blood  |
|                                                                       |
|                                                   Virus Division\     |
|                                                                       |
|                                                   Redmond, WA\        |
|                                                                       |
|                                                   US License 1109     |
|   ------------------ -                                                |
| ----------- ------------ ------------ ------------------ ------------ |
+-----------------------------------------------------------------------+

 

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

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

 

## HIV-1 Antigen Assays

  ------------------ ------------ ------------- ---------------- ------------------- ------------
  **Tradename(s)**   **Format**   **Sample**    **Use**          **Manufacturer**    **Approval
                                                                                     Date**

  Abbott HIVAG-1     EIA          Serum /       Donor Screen /   Abbott              4/23/1996
  Monoclonal                      Plasma        Prognosis &      Laboratories\       
                                                Neut. Kit        Abbott Park, IL\    
                                                                 US License 0043     

  Coulter HIV-1 p24  EIA          Serum /       Donor Screen /   Coulter             3/14/1996
  Ag Assay;\                      Plasma        Prognosis &      Corporation\        
  HIV-1 p24 Antigen                             Neut. Kit        Miami, FL\          
  ELISA Test System                                              US License 1185     

  Abbott HIVAG-1     EIA          Serum /       Prognosis &      Abbott Laboratories 8/3/1989
                                  Plasma        Neut. Kit                            

  Coulter HIV-1 p24  EIA          Viral Culture Prognosis        Coulter Corporation 3/14/1996
  Ag Assay                        Supernatant   (Quantitative) &                     
                                                Neut. Kit                            
  ------------------ ------------ ------------- ---------------- ------------------- ------------

### Anti-HIV-1 Oral Specimen Collection Device

  ------------------ ------------ ------------ -------------- -------------------- ------------
  **Tradename(s)**   **Format**   **Sample**   **Use**        **Manufacturer**     **Approval
                                                                                   Date**

  Epitope OraSure    Oral         Oral Fluid   For Use in     Epitope, Inc.\       12/23/1994
  HIV-1 Oral         Specimen                  Designated     Beaverton, OR        
  Specimen           Collection                Non-Donor                           
  Collection Device  Device                    Screen and                          
                                               Non-Donor                           
                                               Supplemental                        
                                               Assays                              
  ------------------ ------------ ------------ -------------- -------------------- ------------

## Anti-HIV-1 Testing Service

  -------------------------------------------------- ------------ ------------ ------------- -------------------- ------------
  **Tradename(s)**                                   **Format**   **Sample**   **Use**       **Manufacturer**     **Approval
                                                                                                                  Date**

  [Home Access HIV-1 Test                            Dried Blood  Dried Blood  Non-Donor     Home Access Health   7/22/1996
  System](http://www.fda.gov/cber/pma/P950002.htm)   Spot         Spot         Screen        Corp.\               
                                                     Collection                              Hoffman Estates, IL  
                                                     Device                                                       
  -------------------------------------------------- ------------ ------------ ------------- -------------------- ------------

## 

## HIV-1 /HCV Nucleic Acid Testing

  ------------------------------------------------------------------ --------------- ------------ ------------- -------------------- ------------
  **Tradename(s)**                                                   **Format**      **Sample**   **Use**       **Manufacturer**     **Approval
                                                                                                                                     Date**

  [Roche Amplicor HIV-1 Monitor                                      PCR             Plasma       Prognosis /   Roche Molecular      3/2/1999
  Test](http://www.fda.gov/cber/pma/p9500054.htm)                                                 Patient       Systems, Inc.\       
                                                                                                  Management\   Branchburg Township, 
                                                                                                  HIV-1 Viral   NJ                   
                                                                                                  Load Assay                         

  [NucliSens HIV-1 QT](http://www.fda.gov/cber/pma/p0100010.htm)     NASBA           Plasma       Prognosis /   bioMerieux, Inc.\    11/19/2001
                                                                                                  Patient       100 Rodolphe Street\ 
                                                                                                  Management\   Durham, NC 27712     
                                                                                                  HIV-1 Viral                        
                                                                                                  Load Assay                         

  COBAS Ampliscreen HIV-1 Test                                       PCR             Plasma       Donor Screen  Roche Molecular      12/20/2002
                                                                                                                Systems, Inc\        
                                                                                                                4300 Hacienda Drive\ 
                                                                                                                Pleasanton, CA 94566 

  [Procleix](http://www.fda.gov/cber/products/hivhcvgen022702.htm)   HIV-1/HCV       Plasma       Donor Screen  Gen-Probe\           2/8/2002
                                                                     Nucleic Acid                               10210 Genetic Center 
                                                                     Test (TMA)                                 Dr\                  
                                                                                                                San Diego, CA 92121  

  Trugene HIV-1 Genotyping Kit and Open Gene DNA Sequencing          HIV-1           Plasma       Patient       Visible Genetics,    4/24/2002
                                                                     Genotyping                   Monitoring    Inc.\                
                                                                                                                700 Bay Street ,     
                                                                                                                Suite 1000\          
                                                                                                                Toronto, CA          

  [UltraQual HIV-1 RT-PCR                                            PCR             Plasma       Donor Screen  National Genetics    9/18/2001
  Assay](http://www.fda.gov/cber/products/hiv1ngi091801.htm)                                                    Institute\           
                                                                                                                Los Angeles, CA      
                                                                                                                92121                

  [UltraQual HCV RT-PCR                                              PCR             Plasma       Donor Screen  National Genetics    9/18/2001
  Assay](http://www.fda.gov/cber/products/hepcngi091801.htm)                                                    Institute\           
                                                                                                                Los Angeles, CA      
                                                                                                                92121                

  [ViroSeq HIV-1 Genotyping                                          HIV-1           Plasma       Patient       Applied Biosystems\  12/10/2002
  System](http://www.fda.gov/cber/510k/k010024.htm)                  Genotyping                   Monitoring    Foster City, CA      
                                                                                                                94404                

  Versant HIV-1 RNA 3.0 (bDNA)                                       Signal          Plasma       Patient       Bayer Corporation\   9/11/2002
                                                                     amplification                Monitoring    Berkeley, CA 94702   
                                                                     nucleic acid                                                    
                                                                     probe                                                           

  [COBAS AmpliScreen HCV                                             PCR             Plasma       Donor Screen  Roche Molecular      12/3/2002
  Test](http://www.fda.gov/cber/products/cobaroc120302.htm)                                                     Systems, Inc\        
                                                                                                                4300 Hacienda Drive\ 
                                                                                                                Pleasanton,          
                                                                                                                California           
                                                                                                                94566-0990           
  ------------------------------------------------------------------ --------------- ------------ ------------- -------------------- ------------