INCSTAR HSV I/II IGG FAST ELISA ASSAY

INCSTAR HSV I/II IGG FAST ELISA ASSAY is an FDA 510(k)-cleared medical device (K955362) manufactured by Incstar Corp.. This device is classified under the Pathology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 23, 1996. Regulation: 8.