CLA-2-30:OT:RR:NC:N2:238
Ms. Paula Swanson
Sanofi Pasteur
1 Discovery Drive
Swiftwater, PA 18370
RE: The tariff classification of Laboratory Reagents for Detecting Dengue Virus Antibodies in Human Serum from Thailand
Dear Ms. Swanson:
In your letter dated April 29, 2011, you requested a tariff classification ruling. The information submitted was sent to our Laboratory for analysis.
Laboratory Regents for Detecting Dengue Virus Antibodies in Human Serum consists of prepared slides of a functional assay for detection of Dengue virus antibodies in human serum. Diluted serum is incubated with a concentration of Dengue virus which is added to a 24 well plate with Vero cell monolayers. The plates are immunostatined with Dengue specific monoclonal antibodies, Alkaline Phosphatase (AP) conjugated anti-mouse IgG and BCIP/NBT substrate. You state in your letter it will only be used for testing verification results and is not intended for the prevention, treatment, diagnosis or cure of diseases, injuries or conditions in humans.
You suggest classification in subheading 3822.00.1090, 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: Containing antigens or antisera: Other.” The monoclonal antibodies impart the essential character of the laboratory reagents, which would be excluded from classification under subheading 3822.00.1090, HTSUS, by the language contained in Harmonized System Explanatory Note 38.22, HTSUS, and Harmonized System Explanatory Notes 30.02(C) and 30.02(E), HTSUS.
The applicable subheading for the Laboratory Regents for Detecting Dengue Virus Antibodies in Human Serum 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.
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 merchandise 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.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
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 at (646) 733-3033.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division