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NY J86723




July 14, 2003

CLA-2-30:RR:NC:2:238 J86723

CATEGORY: CLASSIFICATION

TARIFF NO.: 3002.10.0190

Mr. Juan E. Lozada
J. Lozada Distributors
Ciudad Jardin I
Alheli No. 60
Toa Alta, PR 00953

RE: The tariff classification of ACON® hCG One Step Pregnancy Test Device (Urine/Serum) from China

Dear Mr. Lozada:

In your letter dated July 1, 2003, you requested a tariff classification ruling.

According to the package insert, which was submitted with your letter, the ACON® hCG One Step Pregnancy Test Device (Urine/Serum) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum, to aid in the early detection of pregnancy. The test device consists of a plastic cassette-like device containing a membrane coated with anti-hCG particles and anti-hCG, plus a disposable specimen dropper, both of which are put up in a sealed pouch. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG in urine or serum.

The assay is conducted by adding a urine or serum specimen to the specimen well of the test device and observing the formation of colored lines. A positive test results with the appearance of two distinct red lines on the membrane, one in the control (“C”) region and the other in the test (“T”) region. A negative test results in the appearance of only one red line in the “C” region, with no apparent pink or red line appearing in the “T” region. The test provides a presumptive diagnosis for pregnancy. However, the individual is advised that a confirmed pregnancy diagnosis should only be made by a physician after the requisite clinical and laboratory findings have been evaluated.

Pursuant to Explanatory Notes 3002(E) and 3822, HTS, the applicable subheading for the subject product will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTS), which provides for “Antsera and other blood fractions and modified immunological products, whether or not obtained by 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 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 646-733-3033.

Sincerely,

Robert B. Swierupski

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