CLA-2-38:RR:NC:2:238 B85221
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