VIRGO(R) MICROWELL ALT ASSAY

VIRGO(R) MICROWELL ALT ASSAY is an FDA 510(k)-cleared medical device (K884784) manufactured by Electro-Nucleonics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 28, 1988. Regulation: 8.