CLA-2-30:OT:RR:NC:N2:238
Mr. Jorge de Tuya
Tuya International Trade Advisors
4642 SE Shady Ridge Lane
Stuart, FL 34997
RE: The tariff classification of NycoCard® U-Albumin Test and NycoCard® U-Albumin Control Kit from Norway
Dear Mr. de Tuya:
In your letter dated March 27, 2012, on behalf on your client, Innova Technologies, Inc., you requested a tariff classification ruling. We apologize for the delay as the information submitted was sent to our laboratory for analysis.
The subject product, NycoCard® U-Albumin Test and NycoCard® U-Albumin Control, is a diagnostic kit which is intended to measure the albumin (a plasma protein) in urine. It is used as an aid in the diagnosis of kidney and intestinal disease. The kit consists of the following: 24 units of plastic test device containing a membrane coated with monoclonal anti-albumin antibodies, 24 quantities of R1/Dilution Liquid in 1.0 mL phosphate buffer (pH 5.6) with less than 10% organic solvent and a small amount of yellow pigment, 2.0 mL of R2/Conjugate with borate buffered solution containing monoclonal anti-albumin antibodies labeled with ultra-small gold particles, 2.0 mL of R3/Wash Solution phosphate buffered NaC1 solution (pH 7.4) and a NycoCard® U-Albumin Control Kit. The control kit contains one positive and one negative control of liquid human urine with greater than 0.1% sodium azide.
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.” In our opinion, the monoclonal antibodies impart the essential character to the kit, 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 NycoCard® U-Albumin Test and NycoCard® U-Albumin Control Kit 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 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,
Thomas J. Russo
Director
National Commodity Specialist Division