The tariff classification of an in-vitro diagnostic kit forthe quantitative determination of serum IgM antibodies toganglioside M, from Switzerland

NY 882527 March 4, 1993 CLA-2-38:S:N:N7:238 882527 CATEGORY: Classification TARIFF NO.: 3822.00.1090 Ms. Janet F. Conley American Laboratory Products Company PO Box 451 Windham, NH 03087 RE: The tariff classification of an in-vitro diagnostic kit for the quantitative determination of serum IgM antibodies to ganglioside M, from Switzerland Dear Ms. Conley: In your letter dated February 1, 1993, you requested a tariff classification ruling. The product in question, Anti-Ganglioside M Antibodies EIA Assay, is an enzyme-linked immunosorbent assay (ELISA), in kit form, for the detection of anti-GM antibodies from the serum of patients suspected of having certain neurological disorders. The kit contains the following components: 1) GM-coated microtiter plate with holder, each plate consisting of six 16-well strips precoated with ganglioside GM (the antigenic component), 2) wash buffer concentrate, 3) positive and negative controls, 4) enzyme label (anti-human IgM antibody conjugated to horseradish peroxidase), 5) OPD tablets, 6) buffered peroxide solution, and, 7) stop solution. The applicable subheading for this product will be 3822.00.1090, Harmonized Tariff Schedule of the United States (HTS), which provides for composite diagnostic or laboratory reagents, other than those of heading 3002 or 3006: containing antigens or antisera: other. The rate of duty will be free. This merchandise may be subject to the regulations of the Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, MD 20857, telephone number (202) 443- 3380. This ruling is being issued under the provisions of Section 177 of the Customs Regulations (19 C.F.R. 177). A copy of this ruling letter should be attached to the entry documents filed at the time this merchandise is imported. If the documents have been filed without a copy, this ruling should be brought to the attention of the Customs officer handling the transaction. Sincerely, Jean F. Maguire Area Director New York Seaport