VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY is an FDA 510(k)-cleared medical device (K951799) manufactured by Light Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 1996. Regulation: 8.