CLA-2-30:OT:RR:NC:2:238
Ms. Andrea Abraham
Meeks, Sheppard, Leo & Pillsbury
1735 Post Road, Suite 4
Fairfield, CT 06824
RE: The tariff classification of Hemo bioscience HBS- C3 Control Cells. No country of origin was provided.
Dear Ms. Abraham:
In your letter dated August 30, 2013, you requested a tariff classification ruling on behalf of Ortho Clinical Diagnostics.
The subject product, Hemo bioscience HBS- C3 Control cells are intended for use as a control of the antiglobulin test performed with Anti-Human Globulin containing anti-C3. The C3 Control cells are added to negative tests, centrifuged and read. According to the technical literature in your submission, C3 Control cells are prepared by coating human red blood cells with C3b (C3c/C3d) using a modified Fruitstone method. These red blood cells are supplied as a 2-4% suspension in a diluent solution with various preservatives. C3 Control Cells are indicated for in vitro diagnostic use only and are supplied ready for use in 3mL vials.
The applicable subheading for the Hemo bioscience HBS- C3 Control cells imported in 3mL vials will be 3002.10.0290, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera, other blood fractions and 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. You may contact them at 1600 Clifton Road, Atlanta, GA 30333, telephone number (404) 633-5313 or (800) CDC-INFO, or at the Web address [email protected].
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 Judy Lee at (646) 733-3033.
Sincerely,
Gwenn Klein Kirschner
Acting Director
National Commodity Specialist Division