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

Emil Bjurling
Mercodia AB
Sylveniusgatan 8A
Uppsala 75450
Sweden

RE: The tariff classification of diagnostic ELISA kits from Sweden

Dear Mr. Bjurling:

In your letter dated January 28, 2026, you requested a tariff classification ruling. Additional information was provided via email dated February 12, 2026.

Mercodia Glucagon ELISA kit (10-1271-01) is a solid phase two-site enzyme immunoassay. It is based on the direct sandwich technique in which two monoclonal antibodies are directed against separate antigenic determinants on the glucagon molecule. During the first incubation glucagon in the sample reacts with anti-glucagon antibodies bound to microplate wells. After washing, peroxidase conjugated anti-glucagon antibodies are added. After a second incubation and a simple washing step, the bound conjugate is detected by reaction with 3,3’,5,5’-tetramethylbenzidine (TMB). The reaction is stopped by adding acid to give a colorimetric endpoint that is read spectrophotometrically. The kit is intended to measure the pancreatic hormone glucagon in plasma and serum. Glucagon measurements are used in the diagnosis and treatment of patients with various disorders of carbohydrate metabolism, including diabetes mellitus, hypoglycemia, and hyperglycemia. The kit contains one coated plate (mouse monoclonal anti-glucagon), one vial each of calibrators 1, 2, 3, 4, and 5 (synthetic glucagon), one vial of calibrator 0, one bottle of assay buffer, one bottle of enzyme conjugate 11X, one bottle of enzyme conjugate buffer, one bottle of wash buffer 21X, one bottle of substrate TMB, and one vial of stop solution.

Mercodia Mouse Insulin ELISA kit (10-1247-01) is a solid phase two-site enzyme immunoassay. It is based on the direct sandwich technique in which two monoclonal antibodies are directed against separate antigenic determinants on the insulin molecule. During incubation insulin in the sample reacts with peroxidase-conjugated anti-insulin antibodies and anti-insulin antibodies bound to microplate wells. A simple washing step removes unbound enzyme labeled antibody. The bound conjugate is detected by reaction with 3,3’,5,5’-tetramethylbenzidine. The reaction is stopped by adding acid to give a colorimetric endpoint that is read spectrophotometrically. The kit provides a method for the quantitative determination of insulin in mouse serum or plasma. The kit contains one coated plate (mouse monoclonal anti-insulin), one vial each of calibrators 1, 2, 3, 4, and 5 (mouse insulin), one vial of calibrator 0, one vial of enzyme conjugate 11X, one vial of enzyme conjugate buffer, one bottle of wash buffer 21X, one bottle of substrate TMB, and one vial of stop solution. You confirm that both kits contain antigens.

The applicable subheading for the Mercodia Glucagon ELISA kit and Mercodia Mouse Insulin ELISA kit will be 3822.19.0030, 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, whether or not put up in the form of kits, other than those of heading 3006; certified reference materials: 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: Containing antigens or antisera: 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 Frequently Asked Questions on the Trade Remedy/IEEPA page at https://www.cbp.gov/trade/programs-administration/trade-remedies/IEEPA-FAQ.

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)
Denise Faingar
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division