The tariff classification of Cervimax™ IHC Monoclonal Antibody Kit from Italy

N186577 October 24, 2011 CLA-2-30:OT:RR:E:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3002.10.0190 Ms. Laura Muzzolini Adriacell SpA s.s. 14 Km, 163, 5 Trieste, 34149 Italy RE: The tariff classification of Cervimax™ IHC Monoclonal Antibody Kit from Italy Dear Ms. Muzzolini: In your letter dated September 28, 2011, you requested a tariff classification ruling. A company brochure was also submitted to this office for our review. The subject product, Cervimax™ IHC Monoclonal Antibody Kit, is used for the immunohistochemical detection of E7 Antigen. Specifically, it is used for the detection of E7 protein expression in paraffin-embedded tissues or paraformaldehyde-immobilized cells by immunohistochemical staining. E7 is the predominant oncoprotein in Human Papilloma Virus (HPV) related cancer. The kit provides sufficient reagents to perform 40 reactions containing two ready to use reagents in 1.7 ml bottles. The first reagent contains an immunohistochemistry (IHC) blocking solution that reduces background staining by blocking excess binding sites on tissues. The second reagent is a mixture of ready-to-use monoclonal antibodies that specifically detect high risk Human Papilloma Virus (HPV) E7 oncogenic proteins. You indicate in your letter, the kit contains affinity purified antibodies from a specific target antigen isolated from mice serum and stabilizers such as bovine serum albumin and sodium azide. You also state the Cervimax™ IHC Monoclonal Antibody Kit will be used exclusively for research purposes only. In our opinion, the monoclonal antibody reagents impart the essential character to the kit. The applicable subheading for the Cervimax™ IHC Monoclonal Antibody 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 merchandise may 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 Rd., Atlanta, GA 30333. You may contact them, by telephone, at: (404) 639-3534 / (800) 311-3435.This merchandise 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 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 Judy Lee at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division