CLA-2-30:OT:RR:NC:N1:138
Ms. Victoria Woodcock
Abcam PLC
330 Cambridge Science Park
Cambridge, CB4 0FL
United Kingdom
RE: The tariff classification of the Human Insulin ELISA (Enzyme-Linked Immunosorbent Assay) kit from the United States and imported from the United Kingdom
Dear Ms. Woodcock:
In your letter dated September 3, 2018, you requested a tariff classification ruling. You also submitted a product datasheet (Human Insulin Elisa Kit ab100578) for our review.
Abcam’s Human Insulin ELISA (Enzyme-Linked Immunosorbent Assay) kit is an in vitro enzyme-linked immunosorbent assay for the quantitative measurement of Human Insulin and Proinsulin in serum, plasma, cell culture supernatants. This assay employs an antibody specific for Human Insulin coated on a 96-well plate. Standards and samples are pipetted into the wells and Insulin present in a sample is bound to the wells by the immobilized antibody. The wells are washed and biotinylated anti-Human Insulin antibody is added. After washing away unbound biotinylated antibody, HRP-conjugated streptavidin is pipetted to the wells. The wells are again washed, a TMB substrate solution is added to the wells and color develops in proportion to the amount of Insulin bound. The Stop Solution changes the color from blue to yellow, and the intensity of the color is measured at 450 nm.
The kit is packed for retail sale and contains the following components:
1 x 96 tests
20X Wash Buffer Concentrate
1 x 25 ml 500X HRP-Streptavidin Concentrate
1 x 200 µl 5X Assay Diluent B
1 x 15 ml Assay Diluent A
1 x 30 ml Biotinylated anti-Human Insulin (lyophilized)
2 vials Insulin Microplate (12 strips x 8 wells)
1 unit Recombinant Human Insulin Standard (lyophilized)
2 vials Stop Solution
1 x 8 ml TMB One-Step Substrate Reagent 1 x 12 ml
In a follow-up email to this office, you indicated this kit contains a pre-coated 96-well strip microplate with the components mentioned above and the 1 x 30 ml Biotinylated anti-Human Insulin (lyophilized) is also known as biotinylated anti-Human Insulin antibody. Pursuant to Explanatory Note 30.02(C)(2) and (E), HTSUS, the antibody imparts the essential character to the kit. You also stated the kit is made in the United States but will be shipped back into the United States from the United Kingdom (UK) and no manufacturing operations are performed in the UK.
The applicable subheading for the Human Insulin Elisa Kit will be 3002.15.0000, 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: Immunological products, put up in measured doses or in forms or packings for retail sale.”
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 the World Wide Web at https://hts.usitc.gov/current.
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 merchandise may also 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 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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division