The tariff classification of Emit® d.a.u.® Opiate Assay

N002892 November 15, 2006 CLA-2-30:RR:E:NC:2:238 CATEGORY: Classification TARIFF NO.: 3002.10.0190 Ms. Beverly A. Kates Dade Behring Inc. 200 Centerpoint Boulevard New Castle, DE 19720 RE: The tariff classification of Emit® d.a.u.® Opiate Assay Dear Ms. Kates: In your letter dated November 1, 2006, you requested a tariff classification ruling. According to the submitted monograph, the subject product, Emit® d.a.u.® Opiate Assay, is an in-vitro enzyme immunoassay, put up in kit form, used to detect the presence of natural and synthetic opiates (e.g., morphine, heroin, codeine, hydromorphone) in human urine. The monograph also indicates that it is able to detect “high concentrations” of meperidine (an analgesic (narcotic) drug)) and nalorphine (a narcotic-antagonist drug). You believe that the kit is correctly classified within subheading 3822.00.5090, HTSUS, which provides for other prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002, HTSUS, or 3006, HTSUS. However, in our opinion, the sheep antibodies contained in the kit impart its essential character. Accordingly, the kit would be excluded from heading 3822, HTSUS, by The Harmonized System Explanatory Notes for heading 3822, HTSUS, which indicate that “diagnostic kits having the essential character of products of heading 30.02 or 30.06 (e.g., those based on monoclonal or polyclonal antibodies) are excluded” (from heading 3822, HTSUS). The applicable subheading for the subject kit will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other.” The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/. This product may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This product may also be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, located at 1600 Clifton Road, Atlanta, GA 30333. You may contact them by telephone at (404) 639-3311. 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 Director, National Commodity Specialist Division