CLA-2-38:OT:RR:NC:N2:238
Ms. Deborah B. Stern
Sandler, Travis & Rosenberg, P.A.
1000 NW 57th Court, Suite 600
Miami, FL 33126
RE: The tariff classification of various Roche laboratory reagents as calibrators and controls for clinical chemistry analyzers
Dear Ms. Stern:
In your letter dated July 11, 2011, you requested a tariff classification ruling on behalf of your client, Roche Diagnostics Operations, Inc. We apologize for the delay. The information submitted was sent to our Laboratory for analysis.
The first product, C.f.a.s (Calibrator for automated systems), consists of thirteen 3 mL bottle of reagent solutions of lyophilized human serum with added substances originating from human or animal biological material. It is intended for use in the calibration of Roche clinical chemistry analyzers before testing a human sample.
The second product, Preciset TDM I, consists of six 5 mL bottle of reagent solutions of human serum and one 10mL diluent of negative human serum used for the dilution of high samples or as a blank sample. Each calibrator bottle contains different concentrations of drugs with preservative and stabilizer. It is intended for use in the calibration of the Roche assays for the quantitative determination of digoxin, carbamazepine, gentamicin, phenyotin, Phenobarbital, primidone, theophylline, tobramycin, valporic acid and vanomycin in human serum and plasma on Roche clinical chemical analyzer.
The third product, Preciset DAT Plus I, consists of six bottles of 5mL reagent solutions containing human urine with drug or drug metabolite. It is used to calibrate the chemistry analyzer prior to testing human urine for presence and concentrations of controlled substances including Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Methaqualone, Opiates, PCP (phencyclidine) and PPX ( propoxyphene).
The fourth product, Digoxin CalCheck 5, consists of five bottles of 2 ml reagent solutions of various levels of Digoxin in bovine serum/albumin buffer matrix. It is intended for use as assayed controls for calibration verification.
The last product, PreciControl Tumor Marker, is a kit consisting of four bottles of 3 mL reagent solutions of lyophilized serum based on human serum, 2 barcodes, control barcode sheets, 2x2 labeled empty snap-cap bottles, 2x10 bottle labels. It is used for verifying the accuracy and precision of elecsys immunoassays for testing tumor markers before testing a human sample. In this case, the lyophilized human serum imparts the essential character of the kit for tariff classification purposes.
The applicable subheading for the C.f.a.s (Calibrator for automated systems), Preciset TDM 1, PreciControl Tumor Marker, all consisting of human serum will be 3002.10.0190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes: Other.” The rate of duty will be free.
The applicable subheading for the Digoxin CalCheck 5 and Preciset DAT Plus I, will be 3822.00.5090, Harmonized Tariff Schedule of the United States (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: 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.
Preciset DAT Plus I may be subject to the Controlled Substances Act, which is administered by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. Information on the Controlled Substances Act can be obtained by contacting the DEA at (800) 882-9539, or by visiting their website at www.dea.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,
Robert B. Swierupski
Director
National Commodity Specialist Division