The tariff classification of Precise One-Step Pregnancy Test and RapidVue 1-Step Pregnancy Test from Mexico

NY C86217 April 22, 1998 CLA-2-30:RR:NC:2:238 C86217 CATEGORY: Classification TARIFF NO.: 3002.10.0090 Judith A. Lee, Esq. Gibson, Dunn & Crutcher LLP 1050 Connecticut Avenue, N.W. Washington, D.C. 20036-5306 RE: The tariff classification of Precise One-Step Pregnancy Test and RapidVue 1-Step Pregnancy Test from Mexico Dear Ms. Lee: In your letters dated March 23, 1998, and April 2, 1998, you requested, on behalf of your clients, Continental Lab Products, Inc., and Quidel Corporation, a tariff classification ruling. The two submitted samples, Precise One-Step Pregnancy Test and RapidVue 1-Step Pregnancy Test, consist of in-vitro diagnostic test kits, designed for home use, which indicate whether the user is pregnant, by producing a reaction when it comes in contact with a urine sample. According to the product literature, the tests are designed to detect, by means of various antibodies contained in the kits, the presence of hCG (Human Chorionic Gonadotropin), which begins to appear in the urine as early as the first day of a missed period. If the test result is positive, hCG has been detected in the urine, and the individual can assume that she is pregnant. The Precise test kit contains two test cassettes, each in a sealed foil packet; two droppers; and two plastic cups (i.e., supplies needed to carry out two tests). The RapidVue test kit contains one test device, put up in a sealed, foil packet. Pursuant to General Rule of Interpretation 3(b), Harmonized Tariff Schedule of the United States (HTS), the applicable subheading for both products will be 3002.10.0090, HTS, which provides for: "Antisera 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) 443-6553. 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 212-466-5770. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division