The tariff classification of coated microparticles, for use in electrochemiluminescence-based immunoassays, from Germany

NY B85221 May 1, 1997 CLA-2-38:RR:NC:2:238 B85221 CATEGORY: Classification TARIFF NO.: 3822.00.5090 Ms. Angela Sharman John A. Steer Company Folcroft West Industrial Park 11 Darby Commons Court Folcroft, PA 19032 RE: The tariff classification of coated microparticles, for use in electrochemiluminescence-based immunoassays, from Germany Dear Ms. Sharman: In your letter dated April 16/97, on behalf of your client, Centocor, Inc., you requested a tariff classification ruling. The subject product consists of coated microparticles, which are referred to as "beads", measuring approximately 3 microns in diameter. The beads are composed of a metallic paramagnetic pigment core, which is encapsulated by a layer of polystyrene. The polystyrene, in turn, is coated with a first layer of biotin, and a second layer of streptavidin, forming a biotin/streptavidin conjugate. The beads are imported put up in suspension form, and are used as the solid phase in electrochemiluminescence-based immunoassays. They serve to immobilize the immune complex (i.e., biotinylated antibody/target antigen in patient's serum/electrochemiluminescent marker antibody) formed in the initial steps of the assay. This is accomplished by the binding of the biotin/streptavidin conjugate on the surface of the bead, to the biotinylated antibody portion of the immune complex. The applicable subheading for the subject product will be 3822.00.5090, Harmonized Tariff Schedule of the United States (HTS), which provides for: "Diagnostic or laboratory reagents on a backing and prepared diagnostic or laboratory reagents whether or not on a backing, other than those of heading 3002 or 3006: Other: Other." The rate of duty will be 2 percent ad valorem. 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 Cornelius Reilly at 212-466-5770. Sincerely, Gwenn Klein Kirschner Chief, Special Products Branch National Commodity Specialist Division