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

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 Aspergillus 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 Aspergillus 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