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NY D84807

December 9, 1998

CLA-2-38:RR:NC:2:238 D84807


TARIFF NO.: 3822.00.5090

Mr. Arnaud Schmutz
Project Manager
Biosepra Inc.
111 Locke Drive
Marlborough, MA 01752

RE: The tariff classification of Heparin HyperD 20 m, Heparin HyperD M, Blue Ceramic HyperD , Lysine Ceramic HyperD , and Methyl Ceramic HyperD chromatographic media, in bulk form, from France

Dear Mr. Schmutz:

In your letter dated August 19, 1998, you requested a tariff classification ruling. Technical information was submitted. We apologize for the delay in our response.

Heparin HyperD 20 m (Part #200750), Heparin HyperD M (Part #200290), Blue Ceramic HyperD (Part #200310), and Lysine Ceramic HyperD (Part #200590) are characterized as affinity chromatographic media, while Methyl Ceramic HyperD (Part #200510) is a hydrophobic interaction chromatographic (HIC) medium. All are in bulk form.

According to the technical information you submitted, Ceramic HyperD media are a range of chromatographic sorbents used for the purification and preparation of protein substances in the laboratory or in industry, the final destination being related to the particle size and particle size distribution (small particles are used at laboratory scale, large particles for high productivity at industrial scale). They are designed for separation in aqueous solutions.

In general, Ceramic HyperD media are composite materials in bead form consisting of a co-polymeric crosslinked network (hydrogel) distributed inside the pores of a rigid, mineral (mixture of sintered zirconium and calcium silicates) "ceramic" support (substrate). The substrate acts as a solid skeleton, while the hydrogel polymer governs the exchange mechanism for macromolecule or particle adsorption. The polymer provides a tridimensional network for the capture of separated molecules. It is insoluble in any solvent, thus preventing the loss of any captured molecules. Affinity ligands are chemically attached to the hydrogel polymers at one end, leaving the other end free to react with the targeted substance to form a complex or coordination compound with that substance. The presence of specific ligands induces, at given pH and ionic strength conditions, a selective adsorption, through the bead-hydrogel structure carrying the ligand, of molecules such as proteins. The adsorbed proteins can then be selectively eluted at precise conditions designed for affinity separation.

Heparin HyperD 20 m and Heparin HyperD M utilize a heparin ligand which specifically interacts with biological products that bind to heparin, such as coagulating factors, growth factors, lipoproteins, etc. These products appear to be particularly efficacious in the purification and production of Antithrombin III. Blue Ceramic HyperD utilizes a Basilen Blue dye as the ligand. This dye bears a specific site that mimics bilirubin and, therefore, binds to albumin. Lysine Ceramic HyperD has an amino acid ligand (lysine). Generally, amino acid chemistry media are utilized in production of serum proteins, peptides, enzymes, etc. The Methyl Ceramic HyperD is a medium filled with hydrophobic (-CH3) functionalized hydrogel. This product has broad application in the purification of proteins.

The applicable subheading for the Heparin HyperD 20 m, Heparin HyperD M, Blue Ceramic HyperD , Lysine Ceramic HyperD , and Methyl Ceramic HyperD will be 3822.00.5090, Harmonized Tariff Schedule of the United States (HTS), which provides for "[d]iagnostic 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: [o]ther: [o]ther." The rate of duty will be 1 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 Harvey Kuperstein at 212-466-5770.


Robert B. Swierupski

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