
Genzyme Diagnostics
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CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST is an FDA 510(k)-cleared medical device (K964155) manufactured by Genzyme Diagnostics. 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 November 24, 1996. Regulation: 8.