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NY N008535

March 26, 2007



TARIFF NO.: 3002.10.0190

Mr. Robert Rieder
Peninsula Laboratories, LLC
305 Old County Road
San Carlos, CA 94070

RE: The tariff classification of an enzyme-linked immunosorbent assay (ELISA) kit (Product No. S-1130)

Dear Mr. Rieder:

In your letter dated March 19, 2007, you requested a tariff classification ruling.

The subject product is an in vitro enzyme-linked immunosorbent assay (ELISA) kit for protein/peptide detection. An ELISA is an immunochemical test involving an enzyme, plus an antibody (or antigen). Enzyme-linked immunosorbent assays are used to detect substances that have antigenic properties (e.g., proteins, hormones, bacterial antigens and antibodies). Basically, an ELISA consists of a solid surface, such as a plate containing depressions or “wells,” onto which an antibody having an affinity for a “target” substance (see above) is coated. A mixture consisting of: a) purified target substance coupled to an enzyme and b) the actual test specimen is added to the test system. If no target substance is present in the test specimen, then only the enzyme-linked purified target substance will bind to the antibody coated on the surface of the wells. Therefore, the more “target” present in the test specimen, the less enzyme-linked purified target substance will be bound. A substance the enzyme acts on is then added, and the amount of the product produced by the enzyme-catalyzed reaction is measured, such as by the change produced in the color of the solution. The resulting color change is indicative of the level of the target substance found in the test specimen. The kit contains, inter alia, lyophilized, diluted primary antiserum (rabbit anti-peptide antiserum) and a plate (i.e., the solid substance) coated with goat anti-rabbit antiserum.

Pursuant to Harmonized System Explanatory Note 38.22, HTSUS, and Harmonized System Explanatory Notes 30.02(C) and (E), HTSUS, the applicable subheading for the subject product will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTSUS), 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.

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/.

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.


Robert B. Swierupski

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