Blood-Grouping Diagnostic Reagents and Kits

Blood-grouping reagents have historically been regulated as biologics under Section 351 of the Public Health Service Act, requiring FDA licensure rather than the 510(k) clearance pathway used for many other IVDs. This means the foreign manufacturer must hold a valid FDA biologics license, and the specific reagent must be listed on that license. Importers should request the manufacturer's FDA biologics license application number and confirm its active status before shipment.

Entry documentation should include the FDA establishment registration number, the biologics license number (or device clearance number if applicable), a certificate of analysis, and labeling that matches the FDA-authorized product. CBP coordinates with FDA for admissibility review, and incomplete documentation can result in detention. Working with a customs broker experienced in FDA-regulated biologics is strongly advisable.