ELISA Test Kit for Human Insulin from Japan

A complete enzyme-linked immunosorbent assay (ELISA) kit designed for quantitative detection of human insulin in serum or plasma samples. This prepared diagnostic reagent kit contains coated microplates, standards, controls, and detection antibodies, classified under HTS 3822.19.0080 as prepared laboratory reagents put up in kit form for in vitro diagnostic use, not of heading 3006.

Duty Rate — Japan → United States

10%

Rate breakdown

9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter

Import Tips

Obtain FDA registration for in vitro diagnostic (IVD) reagents and ensure CLIA waiver status if applicable

Include certificates of analysis (CoA) and safety data sheets (SDS) for all reagents; verify stability data for shelf life

Avoid misclassification as finished pharmaceuticals by providing lab use documentation; declare as research/diagnostic reagents