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NY K82127




March 12, 2004
CLA-2-30:RR:NC:2:238 K82127

CATEGORY: CLASSIFICATION

TARIFF NO.: 3002.10.0190

Mr. Mark Pinchok
Bayer Corporate and Business Services, LLC. 100 Bayer Road
Pittsburgh, PA 15205-9741

RE: The tariff classification of the ADVIA Centaur® HBc IgM ReadyPack® in vitro diagnostic immunoassay kit and the ADVIA Centaur® HBc IgM QC quality control kit, from Ireland

Dear Pinchok:

In your letter dated December 22, 2003, you requested a tariff classification ruling.

The first submitted sample, designated as ADVIA Centaur® HBc IgM ReadyPack®, consists of a paperboard box containing an in-vitro diagnostic immunoassay kit for the detection of IgM antibody to the core antigen of the hepatitis B virus in human serum or plasma. The kit, which is intended for retail sale for use with the ADVIA Centaur® Immunoassay System, contains two liquid-filled plastic cassettes, two liquid-filled plastic vials; and a “master curve card.” Two of the reagents found in the kit consist of monoclonal antibody conjugates, one of which is made up, in part, of recombinant hepatitis B core antigen. Explanatory Note 30.02(C)(2)(c), HTSUS. In our opinion, the antibody-conjugate reagents impart the essential character to the kit. Rule 3(b), General Rules of Interpretation, HTSUS.

The remaining submitted sample, designated as ADVIA Centaur® HBc IgM QC, consists of a paperboard box containing four liquid-filled vials and barcode labels. Two of the vials contain a negative control, which consists of processed human plasma negative for IgM antibodies to HBc antigen. The other two vials contain a positive-control, which consists of processed human plasma positive for IgM antibodies to HBc antigen. The controls are used in conjunction with the appropriate barcode label for monitoring the performance of the ADVIA Centaur® Immunoassay System, so as to control the quality of the ADVIA Centaur® HBc IgM assay.

The applicable subheading for both products will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTS), which provides for “Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-443-6332.

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

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