REAADS IGG ANTI-B2GPI TEST KIT

REAADS IGG ANTI-B2GPI TEST KIT is an FDA 510(k)-cleared medical device (K982391) manufactured by Corgenix, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 1998. Regulation: 8.