In-vitro diagnostic (IVD) substances — reagents, calibrators, controls, and test kits used to analyze human specimens outside the body — are regulated by FDA as medical devices under the Federal Food, Drug, and Cosmetic Act, with most requiring 510(k) clearance, PMA approval, or De Novo authorization before US marketing. The COVID-19 pandemic significantly expanded global IVD trade flows and highlighted supply-chain concentration risks for critical diagnostic inputs. Classification of IVDs under the HTS can be nuanced, as some reagent kits may be classified as chemical preparations while others fall under medical device headings depending on their composition and intended use. Importers should verify FDA device registration and listing status for each product prior to entry.

AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.