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NY B88872




August 26, 1997

CLA-2-38:RR:NC:2:238 B88872

CATEGORY: CLASSIFICATION

TARIFF NO.: 3822.00.1090

Mr. Gary Richardson
Ostex International, Inc.
2203 Airport Way South, Suite 400
Seattle, WA 98134

RE: The tariff classification of NTx Concentrate from Japan

Dear Mr. Richardson:

In your letter dated August 13, 1997, you requested a tariff classification ruling.

The subject product, NTx Concentrate, is a heterogeneous mixture of peptides that is enriched for cross-linked N-telopeptides of type 1 collagen ("NTx"). It is prepared from enzyme-digested human bone. The concentrate contains ~5-10% of NTx, with the remaining 90-95% consisting of peptide and protein by-products from the enzyme digestion during the extraction process. The concentrate is dissolved in an aqueous solution of 0.1% trifluoroacetic acid and 30% acetonitrile, and will be imported in screw-cap vials. Subsequent to importation, the concentrate is diluted with a reagent solution to form two components of an ELISA test kit, namely: the calibration-standard reagents, and the "antigen" coating on the microtiter-plate component of the kit. The assay will be used to monitor human bone resorption rates, with potential applications for: diagnosing and monitoring bone disease, evaluating the effectiveness of antiresorption therapies, and studying normal bone metabolism.

The applicable subheading for the subject product will be 3822.00.1090, 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: Containing antigens or antisera: Other." The rate of duty will be free.

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

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