RE: The tariff classification of rapid diagnostic test kits from China

U.S. Department of Homeland Security U.S. Customs and Border Protection National Commodity Specialist Division One World Trade Center, Suite 51.201 New York, NY 10007 U.S. Customs and Border Protection N364257 August 31, 2026 CLA-2-38:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 3822.19.0080 Matthew Pfeifer iHealth Labs 880 W Maude Ave Sunnyvale, CA 94085 RE: The tariff classification of rapid diagnostic test kits from China Dear Mr. Pfeifer: In your letter dated August 12, 2026, you requested a tariff classification ruling. Additional information was provided via email dated August 20 and August 24, 2026. The items under consideration are the iHealth Flu A&B/COVID-19/RSV Rapid Test (4-in-1), CVS™ COVID-19 & Flu A/B & RSV Antigen Test (4-in-1), iHealth COVID-19/Flu A&B Rapid Test (3-in-1), and iHealth COVID-19 Antigen Rapid Test. These products are immunological diagnostic tests intended for the qualitative detection of specific viral antigens in human respiratory specimens. Based on the documents and email provided, each retail box contains either 1, 2, 4, 5 or 25 tests, depending on the specific product. Each test includes the necessary testing materials: a test card sealed in a pouch, a tube containing extraction solution, and a swab. The test card is a lateral flow immunoassay device used for the qualitative detection, and where applicable differentiation, of viral antigens associated with COVID-19, influenza A, influenza B, and/or RSV (respiratory syncytial virus), depending on the specific product. The test card generally consists of a plastic housing, sample pad, nitrocellulose membrane, absorbent pad, and antibody mix including immobilized antibodies and antibodies conjugated to detection particles such as colloidal gold or latex microspheres. Each card includes a sample well and one or more result windows with control and test lines corresponding to the analytes covered by the specific product, such as COVID-19, Flu A, Flu B, and RSV. You explain that the essential active components of these products are biologically derived monoclonal antibodies and antibody conjugates incorporated into the test system. The monoclonal antibodies and antibody conjugates are produced through biological and biotechnological processes. They possess specific immunological binding activity against corresponding viral antigens, including SARS-CoV-2, influenza A virus, influenza B virus, and RSV, depending on the specific product configuration.
When a respiratory specimen is applied to the test component, target viral antigens in the specimen are recognized and bound by labeled monoclonal antibodies with high specificity. Through the specific interaction between viral antigens and antibodies, antigen-antibody immune complexes are formed and migrate through the membrane. These immune complexes are captured by immobilized antibodies on the test membrane, generating a visible signal for qualitative detection of the target viral antigens. In your letter, you suggest classification in subheading 3002.15.00, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Immunological products, put up in measured doses or in forms or packings for retail sale.” We disagree. Pursuant to Chapter 30 Note 1(ij), diagnostic reagents of heading 3822 are excluded. The applicable subheading for the above rapid diagnostic test kits will be 3822.19.0080, HTSUS, which provides for “Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits, other than those of heading 3006 ...: D iagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, whether or not put up in the form of kits: Other: Other: Other.” The general rate of duty will be free. The duties cited above are current as of this ruling’s issuance. 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 at https://hts.usitc.gov/. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies. 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 800-471-7127, by e-mailing to [email protected], or by visiting their website at www.epa.gov. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Fei Chen at [email protected]. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division