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NY R01498




March 4, 2005

CLA-2-38:RR:NC:2:238 R01498

CATEGORY: CLASSIFICATION

TARIFF NO.: 3822.00.5090; 2827.20.0000

Mr. Kenneth Nelson
BioMedica Diagnostics Inc.
P.O. Box 1030, 94 Wentworth Road
Windsor, NS Canada B0N 2T0

RE: The tariff classification of ™QuikCoag PT with Calcium, ™QuikCoag APTT, ™QuikCoag Calcium Chloride (0.02M), ™QuikCoag Plasma Controls (Levels 1, 2, and 3), and the™QuikCoag Reagents Sample Pack, from Canada

Dear Mr. Nelson:

In your letter dated February 17, 2005, you requested a tariff classification ruling.

The first product, ™QuikCoag PT with Calcium, is a lyophilized preparation consisting of rabbit-brain thromboplastin, calcium chloride, buffer, and 0.05% sodium azide as a preservative. It is used to perform the one-stage prothrombin time (PT) test, and assays which are based on a modified prothrombin time, in order to assess the extrinsic pathway of coagulation. The product is supplied in 4 and 10 mL vials.

The second product, ™QuikCoag APTT, is a preparation consisting of rabbit-brain cephalin and ellagic acid activator, with buffer, stabilizers and preservatives. It is used to perform the activated partial thromboplastin test (APPT), a general screening test for the detection of coagulation abnormalities in the intrinsic pathway of coagulation. The product is supplied in 4 and 10 mL vials.

The third product, ™QuikCoag Calcium Chloride (0.02M), consists of a 0.02M solution of calcium chloride. Sodium azide (0.05% by weight) is added as a preservative. The product is intended for in vitro diagnostic use only in performing PT’s, APPT’s, coagulation factor assays, and recalcification (plasma clotting) times. The product is supplied in 4 and 10 mL vials

The fourth product, ™QuikCoag Plasma Controls (Level 1, 2, and 3), consists of three, separate, coagulation control-reagents, namely: Plasma Control, Level 1; Plasma Control, Level 2; and Plasma Control, Level 3. All three controls consist of lyophilized preparations of human plasma containing buffers and stabilizers, and are intended for use in quality assurance of in vitro diagnostic coagulation tests. Each control is supplied in a 1 mL vial.

The fifth product, ™QuikCoag Reagents Sample Pack, consists of a kit containing all the above-described products in the following quantities: 2 x 4 mL PT with Calcium, 2 x 4 mL APTT (Ellagic Acid), 2 x 4 mL Calcium Chloride (0.02M), 2 x 1 mL Plasma Control Level 1, 1 x 1 mL Plasma Control Level 2, and 1 x 1 Plasma Control Level 3.

The applicable subheading for ™QuikCoag PT with Calcium, ™QuikCoag APTT, ™QuikCoag Plasma Controls (Levels 1, 2, and 3), and the™QuikCoag Reagents Sample Pack will be 3822.00.5090, Harmonized Tariff of the United States (HTS), which provides for “Diagnostic or laboratory reagents on a backing, 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 free.

Pursuant to note 1(d) of Chapter 28, HTS, and exclusion “(b)” to explanatory note 38.22, HTS, the applicable subheading for ™QuikCoag Calcium Chloride (0.02M) will be 2827.20.0000, HTS, which provides for “Calcium chloride.” The rate of duty will be free.

This merchandise may be subject to the requirements of the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, Office of Human Safety, Biosafety Branch. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number 404-633-5313.

This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which is administered by the U.S. Environmental Protection Agency. You may contact them at 401 M Street, S.W., Washington, D.C. 20460, telephone number 202- 554-1404. You may also contact the regional EPA office (Region II) at 212- 637-3526.

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 646-733-3033.

Sincerely,

Robert B. Swierupski

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