The tariff classification of "Phadebact" diagnostic test kits, for the

NY 890090 September 17, 1993 CLA-2-38:S:N:N7:238 890090 CATEGORY: Classification TARIFF NO.: 3002.10.0050 Ms. Patricia Ellis Ellis Int'l. 594 Mexico City Avenue Kansas City, MO 64153 Kansas City International Airport RE: The tariff classification of "Phadebact" diagnostic test kits, for the identification of infectious human diseases, from Sweden Dear Ms. Ellis: In your letter dated September 3, 1993, on behalf of your client, Remel Labs, you requested a tariff classification ruling. The subject merchandise consists of various in-vitro diagnostic test kits for the identification of various pathogenic bacteria, such as Streptococcus pneumoniae, Haemophilus influenza and Neisseria meningitidis, which are the causative agents of several infectious diseases in man. According to the supplied literature, these kits make use of the co-agglutination technique, which employs reagents, consisting of antibodies obtained from rabbits, that have been coated onto the cell surface of dead staphylococcal bacterial cells. These dead bacterial cells serve as "carriers" for the antibodies. The appropriate reagent antibody is then introduced to its corresponding sample antigen (i.e., bacterial pathogen), whose presence is being tested for in the patient's specimen. A positive test is indicated by the coagglutination of the reagent antibody-carrier cell "particles" upon coming into contact with the corresponding or "matching" antigen. The applicable subheading for these test kits will be 3002.10.0050, Harmonized Tariff Schedule of the United States (HTS), which provides for antisera and other blood fractions: other. The rate of duty will be free. This merchandise may be subject to the regulations of the Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, MD 20857, telephone number (202) 857-8400. This ruling is being issued under the provisions of Section 177 of the Customs Regulations (19 C.F.R. 177). A copy of this ruling letter should be attached to the entry documents filed at the time this merchandise is imported. If the documents have been filed without a copy, this ruling should be brought to the attention of the Customs officer handling the transaction. Sincerely, Jean F. Maguire Area Director New York Seaport