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NY 877026


August 19, 1992

CLA-2-38:S:N:N1-F:238 877026

CATEGORY: CLASSIFICATION

TARIFF NO.: 3822.00.1090

Mr. Paul Blackinton
North American Biologicals, Inc.
16500 N.W. 15th Avenue
Miami, FL 33169

RE: The tariff classification of Visuwell Reagin, an enzyme- linked immunosorbent assay (ELISA), in kit form, from Canada.

Dear Mr. Blackinton:

In your letter dated June 30, 1992, resubmitted on July 31, 1992, you requested a tariff classification ruling.

Visuwell Reagin is a nontreponemal enzyme-linked immunosorbent assay (ELISA), in kit form, for the detection of reagin antibodies as a screening test to detect pathogenic treponemal infection in syphilis serology. The kit contains the following components: 1) microwells coated with reagin antigen, 2) positive (reactive human serum) and negative (non-reactive human serum) controls to ensure proper assay performance, 3) conjugate "(C)" reagent (urease-conjugated rabbit polyclonal antibody against human IgG), 4) conjugate diluent "(D)" reagent, 5) urease substrate "(S)" reagent, 6) sodium chloride powder (for preparation of wash solution), 7) uncoated microwells for substrate validation, and, 8) a microwell holder.

The literature supplied by you states that the test is performed with unheated serum or citrated plasma specimens in microwells coated with cardiolipin, lecithin, and cholesterol. The cardiolipin antigen will bind with any reagin antibodies that are present in serum or plasma specimens from syphilitic patients. The patient's specimen is added directly to the sensitized microwell and incubated at room temperature. Any reagin antibodies present in the specimen will bind to the coated microwell and, after the carrying out of several addtional steps in the procedure, can be detected visually or by means of an ELISA reader equipped with a specific type of filter.

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

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