N041653

December 9, 2008

CLA-2-38:OT:RR:NC:2:238

CATEGORY: Classification

TARIFF NO.: 3822.00.5090

Ms. Kristy Thomas

Trans-Port International, Inc.

P.O. Box 746

Charleston, SC 29402

RE: The tariff classification of FXG™: RESP (Asp+) Rapid Detection of
Aspergillus and Pneumocystis DNA Kit (Ref 080-010) and MycXtra™ Fungal
DNA Extraction Kit (Ref 080-005), from England

Dear Ms. Thomas:

In your letter dated October 16, 2008, you requested a tariff
classification ruling. We apologize for the delay and wish to thank you
for your efforts in obtaining additional information.

The FXG™: RESP (Asp+) Rapid Detection of Aspergillus and Pneumocystis
DNA Kit is a Real-Time Polymerase Chain Reaction assay that uses
molecular analysis to detect the presence of both *Aspergillus* spp. and
*Pneumocystis jirovecii*. The kit consists of five sealed
three-compartment foil pouches, each of which contains four tubes. Tube
I contains a buffered solution of DNA Polymerase complex with a passive
reference dye. Tube 2 contains a buffered solution of primers, molecular
beacons and an Internal Amplification Control (a recombinant DNA plasmid
harboring a non-infective sequence unrelated to either A*spergillus* or
*Pneumocystis*). Tube 3 is the negative control (water). Tube 4 is the
buffered positive control DNA (a recombinant plasmid harboring the
target sequences of the A*spergillus* and *Pneumocystis*). The kit is
packed with instructions for use, a plate layout template, and a
certificate of analysis.

The MycXtra™ Fungal DNA Extraction Kit is designed for the isolation and
purification of fungal DNA present in human lower respiratory tract
samples from patients with suspected fungal infections. This kit
utilizes mechanical force as well as chemical lysis to break down the
cell walls of the fungal microorganisms to release the DNA. The DNA is
captured on a silica spin filter, the filter is washed, and the DNA is
recovered in a buffered solution for subsequent Polymerase Chain
Reaction analysis with the FXG™: RESP (Asp+) Kit. The kit contains bead
solution tubes, and a number of solutions containing various chemicals
and detergents to assist in the retrieval of the DNA. It also contains
spin filter units in tubes, microcentrifuge tubes and instructions for
use.

While the FXG™: RESP (Asp+) and the MycXtra™ are intended to be used in
conjunction with each other, they are neither packed nor imported
together. We have been unable to establish the full identity of all the
components of the MycXtra™ Kit.

The applicable subheading for the FXG™: RESP (Asp+) Rapid Detection of
Aspergillus and

Pneumocystis DNA Kit (Ref 080-010) will be 3822.00.5090, Harmonized
Tariff Schedule of the United States (HTSUS), which provides for
"Diagnostic or laboratory reagents on a backing, prepared diagnostic or
laboratory reagents, whether or not on a backing, other than those of
heading 3002 or 3006; ...: Other: Other." The duty rate will be free.

Duty rates are provided for your convenience and are subject to change.
The text of the most recent HTSUS and the accompanying duty rates are
provided on World Wide Web at http://www.usitc.gov/tata/hts/.

Your inquiry does not provide enough information for us to give a
classification ruling on the MycXtra™ Fungal DNA Extraction Kit (Ref
080-005) at this time. Your request for a classification ruling should
include the full chemical identification (names and CAS numbers) by
weight of all the components of the bead solution tubes, the PCR
Inhibitor Removal Solution (IRS), and Solutions S1 through S5. We would
also need a description of the spin filter units in the 2 mL tubes. When
this information is available, you may wish to consider resubmission of
your request. We are returning any related samples, exhibits, etc. If
you decide to resubmit your request, please include all of the material
that we have returned to you.

This ruling is being issued under the provisions of Part 177 of the
Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be
provided with the entry documents filed at the time this merchandise is
imported. If you have any questions regarding the ruling, contact
National Import Specialist Harvey Kuperstein at (646) 733-3033.

Sincerely,

Robert B. Swierupski

Director

National Commodity Specialist Division