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NY F88476




June 30, 2000

CLA-2-30:RR:NC:2:238 F88476

CATEGORY: CLASSIFICATION

TARIFF NO.: 3002.10.0090

Mr. D.G. McKenny
Norman G. Jensen, Inc.
P.O. Box 1439
47 Caswell Avenue
Derby Line, Vermont 05830

RE: The tariff classification of IMMUNOCYT™ from Canada

Dear Mr. McKenny:

In your letter dated June 13, 2000, on behalf of your client, DiagnoCure Inc., you requested a tariff classification ruling.

The subject product, IMMUNOCYT™, is an in-vitro diagnostic test, in kit form, for the detection of bladder cancer. The kit consists of five (5) components (“reagents”), namely: a blocking solution, an antibody solution, a sample fixative, a positive control, and a negative control. The components are put up in a flip-open paperboard box. According to the package insert, “[I]mmunocyt™ is an immunocytofluorescent technique based on a monoclonal antibody cocktail labeled with fluorescent markers. This monoclonal antibody cocktail consists of two antibodies which bind to a mucin glycoprotein, and one antibody specific to a glycosylated form of carcinoembryonic antigen (CEA). These two specific antigens are expressed in a selective fashion by the tumor cells in the bladder. The antibody solution is incubated with urinary cells collected by filtration and transferred to slides. The cells expressing tumor antigens are detected by epifluorescent microscopy.” In our opinion, the essential character of the kit is imparted by the antibody solution.

Pursuant to Rule 3(b) of the General Rules of Interpretation, HTS, and the Explanatory Notes to heading 3822, HTS, the applicable subheading for the subject product will be 3002.10.0090, Harmonized Tariff Schedule of the United States (HTS), which provides for "[A]ntisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other." The general 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 301-443-1544.

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 212-637-7068.

Sincerely,

Robert B. Swierupski

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