CLA-2-38:OT:RR:NC:N3:135

Mr. Prashant Khade
NextGen BioProducts
6076 Corte Del Cedro
Carlsbad, CA 92011

RE: The tariff classification and country of origin of an enhanced chemiluminescence solution (ECL solution) kit from India

Dear Mr. Khade:

In your letter dated August 11, 2020, you requested a tariff classification and country of origin ruling. Additional information was provided via email dated August 17, 2020. The documents provided were submitted to our laboratory for analysis.

The ECL solution kit is comprised of three bottles (tubes), package together for retail sale. Bottle #1 contains a mixture of water and luminol (CAS# 521-31-3). Bottle #2 consists of a mixture of water and p-Coumaric acid (CAS# 501-98-4). Bottle #3 consisits of a mixture of water and hydrogen peroxide (CAS# 7722-84-1). The ECL solution kit will be used as a biology reagent for pharmaceutical and biomedical research use, but it is not for clinical diagnostic procedure or use.

According to our laboratory, the enhanced chemiluminescence solution kit is used for the detection of an analyte. It engages in a chemical reaction in response to an analyte, is consumed during the reaction, and produces an observable or measurable response.

The applicable classification for the ECL solution kit will be 3822.00.5095, HTSUS, which provides for “[d]iagnostic or laboratory reagents on a backing and prepared diagnostic or laboratory reagents, whether or not on a backing, other than those of heading 3002 or 3006; certified reference materials: [d]iagnostic 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: [o]ther: [o]ther.” The general rate of duty will be free.

This merchandise may be subject to the requirements of the Toxic Substances Control Act (TSCA), which are administered by the U.S. Environmental Protection Agency (EPA). Information on the TSCA can be obtained by contacting the EPA at Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C., 20460, by calling the Toxic Substances Control Act Hotline at (202) 554-1404, by e-mailing to [email protected], or by visiting their website at www.epa.gov.

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 https://hts.usitc.gov/current.

COUNTRY OF ORIGIN

The ECL solution kit is manufactured, packed and imported from India directly for retail sale to customers.

"Country of origin" is defined in section 134.1(b), Customs and Border Protection (CBP) Regulations (19 CFR 134.1(b)), as "the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the 'country of origin' within the meaning of this part.”

All three items in the ECL kit are manufactured and originated in India. The luminol, p-Coumaric acid, and hydrogen peroxide were manufactured in India. They are mixed with water respectively in the laboratory and aliquoted into specific bottles - 1, 2 and 3. Since the kit is wholly made in India, its country of origin is India.

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 Fei Chen at [email protected].

Sincerely,

Steven A. Mack
Director
National Commodity Specialist Division