CLA-2-30:OT:RR:E:NC:N2:238

Ms. Helen Mestas
Beckman Coulter Inc.
4300 Harbor Blvd.
Fullerton, CA 92835

RE: The tariff classification of Rubella IgG 34430, TBIL reagent 442745, IgG reagent 446400, Reagent kit IM 1579 RIA Free T3 and GenomeLab™ GeXP Human MetastasisPlex Kit A32712, from France

Dear Ms. Mestas:

In your letter dated November 14, 2007, you requested a tariff classification ruling.

The first product, Rubella IgG 34430, is used for the quantitative and qualitative determination of IgG antibodies to the rubella virus in human serum and aids in the diagnosis of rubella infection. This product contains mouse monoclonal IgG and uses chemiluminescent reaction to determine anti-rubella levels in human serum.

The second product, TBIL reagent 442745, is used for the quantitative determination of bilirubin concentration in human serum or plasma. It is used to measure the total bilirubin concentration by a timed endpoint Diazo method. Per your letter, this reagent does not contain any biological and animal source material, but, rather, contains various chemicals including sodium benzoate, caffeine, sulfanilic acid, HCL, Sodium Nitrite and Sodium Acetate.

The third product, IgG reagent 446400, is used for the quantitative determination of Immunoglobulin G (IGG) in human serum or cerebrospinal fluid (CSF) and is primarily used for in vitro diagnosis. This product contains processed goat sera IGG antibody and processed diluted human serum IGG antigen Excess Solution. The methodology used to determine IGG is by measuring the rate of increase in light scattered from particles suspended in solution as a result of complexes formed during an antigen-antibody reaction.

The fourth product, Reagent Kit IM 1579 RIA Free T3, is intended for in vitro diagnostic use. This kit contains Ligand coated tubes and is radioactive labeled monoclonal antibody in bovine serum albumin and dye. It is used for the quantitative determination of triiodothyronine (T3) in human serum by the principle of the competitive protein binding analysis.

The last product, GenomeLab™ GeXP Human MetastasisPlex Kit A32712, is used with the GenomeLab™ system, a gene expression analysis system used to study gene pathways in human tumor progression. This instant reagent kit contains RT Rev Primer Plex Human, PCR FWD Primer Plex Human, and Control Human RNA Templates, all used for DNA replication.

The applicable subheading for Rubella IgG 34430, IgG reagent 446400 and Reagent kit IM 1579 RIA Free T3, will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other." The rate of duty will be free.

The applicable subheading for the TBIL reagent 442745 and GenomeLab™ GeXP Human MetastasisPlex Kit A32712, will be 3822.00.5090, Harmonized Tariff Schedule of the United States (HTSUS), 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.

The Rubella IgG 34430, IgG reagent 446400, Reagent kit IM 1579 RIA Free T3 and GenomeLab™ GeXP Human MetastasisPlex Kit A32712 may be subject to the rules and regulations of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, located at 1600 Clifton Rd., Atlanta, GA 30333. You may contact them, by telephone, at: (404) 639-3534 / (800) 311-3435.

The TBIL reagent 442745 may be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency (EPA). Information on the TSCA can be obtained by calling the EPA at (202) 554-1404, or by visiting their website at www.epa.gov.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

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
Director,
National Commodity
Specialist Division