CLA-2-30:OT:RR:NC:N2:238
Mr. Kenneth J. Troia
Biotest Microbiology Corporation
400 Commons Way, Suite F
Rockaway, NJ 07866
RE: The tariff classification of PyroDetect Cryoblood from Germany
Dear Mr. Troia:
In your letter dated June 10, 2011, you requested a tariff classification ruling. The information submitted was sent to our Laboratory for analysis.
The subject product, PyroDetect Cryoblood, consists of pooled human whole blood, a phosphate buffer as a pH ionic strength stabilizer, and a cryoprotection agent (DMSO). It will be packaged in 2x2 ml frozen vials and will be used for the detection of pyrogenic activity with the Monocyte-Activation Test (MAT). Based on the literature you provided to this office, the PyroDetect Cryoblood is part of the PyroDetect System for the detection of pyrogens in pharmaceuticals, medical devices and cosmetics using Interleukin 1-ß response. You state in your letter, the Cryoblood will not be imported together with the PyroDetect System due to temperature conditions, specifically; the Cryoblood needs to be at -80 degrees Celsius during transportation.
In your letter, you suggest classification in 3002.90.5150 which provides for “Human blood; …; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other: Other: Other.” In consultation with our Laboratory, we agree with your classification as the product is considered to be other human blood preparation for diagnostic use.
The applicable subheading for the PyroDetect Cryoblood will be 3002.90.5150, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Human blood; …; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other: Other: 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 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