The tariff classification of Combitrol Plus B Multi-Analyte Control

N284927 August 25, 2017 CLA-2-38:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3822.00.5090 Ms. Nina Mohseni Sandler, Travis & Rosenberg, P.A. 225 West Washington Blvd, Suite 1640 Chicago, IL 60606 RE: The tariff classification of Combitrol Plus B Multi-Analyte Control Dear Ms. Mosheni: In your letter dated March 30, 2017, on behalf of Roche Diagnostics Operations, Inc., you requested a tariff classification ruling. We apologize for the delay as the information was sent to our laboratory for analysis. In your letter, you describe Combitrol Plus B as a specially formulated three-level aqueous liquid material used to monitor the measurement of all analytes measured by the Roche OMNI S chemistry analyzer. This multi-analyte control is for in vitro diagnostic use and provides a method of performing periodic quality control checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The control works by simulating patient samples used to verify the calibration and/or assay range for parameters prior to running the assay with patient samples. Combitrol Plus B is packaged for retail sale containing 30 quantities of 1.7 mL glass ampules packaged in 3 boxes labeled as Level 1 (Reference 03321193001), Level 2 (Reference 03321207001) and Level 3 (Reference 03321215001). Combitrol Plus B contains clinically relevant quantities of the targeted analytes, including pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, glucose, lactate, urea, and hematocrit, and suitable concentrations of dyes to simulate clinically relevant values of bilirubin, hemoglobin and hemoglobin derivatives: O2Hb, COHb, MetHb and HHb. Combitrol Plus B does not contain any biological materials. The applicable subheading for the Combitrol Plus B Multi Analyte Control 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 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 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