
Murex Corp.
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MUREX (TM), SUDS (TM), HCG ASSAY is an FDA 510(k)-cleared medical device (K860451) manufactured by Murex Corp.. 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 April 20, 1986. Regulation: 8.