VARICELLA-ZOSTER(IGG) IFA TEST

VARICELLA-ZOSTER(IGG) IFA TEST is an FDA 510(k)-cleared medical device (K841434) manufactured by Zeus Scientific, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 18, 1985. Regulation: 8.