QUANTECH TOTAL B-HCG ASSAY

QUANTECH TOTAL B-HCG ASSAY is an FDA 510(k)-cleared medical device (K990258) manufactured by Quantech , Ltd.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 1999. Regulation: 8.