
Digene Corp.
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MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 is an FDA 510(k)-cleared medical device (K010893) manufactured by Digene Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 2001. Regulation: 8.