The country of origin of particle-enhanced turbidimetric immunoassay components

N362413 July 8, 2026 OT:RR:NC:N3:135 CATEGORY: Origin Martin Schaefermeier Cassidy Levy Kent (USA) LLP 2112 Pennsylvania Avenue NW Washington, DC 20037 RE: The country of origin of particle-enhanced turbidimetric immunoassay components Dear Mr. Schaefermeier: In your letter dated June 17, 2026, on behalf of BÜHLMANN Laboratories AG, you requested a country of origin determination ruling. The products under consideration are the fPELA turbo Reagent, the fCAL turbo Reagent, fCAL turbo Calibrator, and the fCAL turbo Control, which are imported and sold separately. Additional information was provided via email dated June 29, 2026. The fPELA turbo Reagent (also referred to as “B-KPELA-RSET”) is a reagent kit composed of two types of vials, R1 (reaction buffer) and R2 (immunoparticles). R1 consists of a base buffer, proteins (serving as blockers to reduce unintended binding of the R2 reagent to non-analytes), a surfactant, a conserving agent with anti-microbial properties, and deionized water. R2 contains polystyrene beads coated with antibodies (also known as conjugated immune-particles), a base buffer (different from that in R1), a surfactant, a conserving agent with anti-microbial properties, and deionized water. In Norway, antibodies originating from Germany are covalently coupled to US-origin polystyrene beads to produce conjugated immune-particles, a process involving a chemical reaction. The base buffers, blocking proteins, and deionized water are manufactured in Norway. The surfactant is a product of Switzerland and the conserving agent is a product of Germany. The ingredients for R1 and R2 are fully mixed in Norway and then filled into vials; this mixing does not involve a chemical reaction. After quality control testing, the products are shipped to Switzerland. In Switzerland, R1 and R2 undergo inspection and additional quality control testing, and are then packaged into the fPELA turbo Reagent kit. The fCAL turbo Reagent (also referred to as “B-KCAL-RSET”) is a reagent kit composed of two types of vials, R1 (reaction buffer) and R2 (immunoparticles). The R1 and R2 vials contain the same ingredients as those in the fPELA turbo Reagent, except that R1 in the fCAL turbo Reagent uses a different base buffer. The manufacturing processes performed in Norway and Switzerland are the same as for the fPELA turbo Reagent, except that the antibodies are sourced from Norway. The fCAL turbo Calibrator (also referred to as “B-KCAL-CASET”) is a calibrator kit composed of six vials containing human calprotectin (the analyte) at different concentrations. Each vial consists of human calprotectin, a base buffer, a surfactant, two conserving agents, a blocker (to reduce unintended binding of the R2 reagent to non-analytes), and deionized water. The base buffer, surfactant, one of the conserving agents, and blocker are made in Switzerland, while the other conserving agent is made in Germany. The human calprotectin is produced in Norway, where it is added to the base buffer in six specified concentrations to form six analyte mixtures. This mixing occurs in Norway and does not result in a chemical reaction. The bulk analyte mixtures are then shipped to Switzerland. In Switzerland, the analyte mixtures at different concentrations are mixed with the remaining ingredients; this mixing also does not involve a chemical reaction. The final mixtures are filled into vials, which are then inspected and packaged as the fCAL turbo Calibrator kit. The fCAL turbo Control (also referred to as “B-KCAL-CONSET”) is a control kit composed of three sets, each including two vials of human calprotectin (the analyte) at different concentrations (low and high). Each vial consists of human calprotectin, a base buffer, a surfactant, two conserving agents, a blocker (to reduce unintended binding of the R2 reagent to non-analytes), and deionized water. The source of the ingredients and the manufacturing processes occuring in Switzerland and Norway are the same as those used for the fCAL turbo Calibrator. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). In determining whether a substantial transformation occurs in the manufacture of products from chemicals, U.S. Customs and Border Protection has consistently examined whether a chemical reaction occurs when two chemicals are mixed in the production of the final article. Regarding the R1 of the fPELA turbo Reagent and fCAL turbo Reagent, in Norway, the Norway-origin base buffers and proteins are mixed with additives, filled into vials, and then tested. The inspection and further testing in Switzerland do not result in a substantial transformation. Hence, the country of origin of the R1 of both the fPELA turbo Reagent and fCAL turbo Reagent will be Norway. Regarding the R2 of the fPELA turbo Reagent and fCAL turbo Reagent, the conjugated immune-particles are produced in Norway through a chemical reaction, which forms a new article. In Norway, Norway-origin conjugated immune-particles and base buffers are mixed with the additives, filled into vials, and then tested. The inspection and further testing in Switzerland do not result in a substantial transformation. Hence, the country of origin of the R2 of both the fPELA turbo Reagent and fCAL turbo Reagent will be Norway. Merely packaging R1 and R2 of the fPELA turbo Reagent into a retail box does not constitute a substantial transformation. As such, the country of origin of the fPELA turbo Reagent will be Norway. Likewise, the country of origin of the fCAL turbo Reagent will be Norway. Regarding the fCAL turbo Calibrator and fCAL turbo Control, the Norway-origin human calprotectin is added to the Switzerland base buffer at different concentrations to form specific analyte mixtures in Norway. The analyte mixtures are mixed with the remaining ingredients, filled into vials, inspected, and packaged into individual kits. The mixing operations in Norway and Switzerland do not involve a chemical reaction. The Norway-origin human calprotectin is the essential ingredient of the calibrator and control and does not undergo a substantial transformation in Switzerland. Accordingly, the country of origin of the fCAL turbo Calibrator and fCAL turbo Control will be Norway. 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 fei.chen@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division