SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS

SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS is an FDA 510(k)-cleared medical device (K914022) manufactured by Pharmacia Diagnostics, 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 January 26, 1992. Regulation: 8.