
Diagnostic Hybrids, Inc.
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ELVIS HSV ID AND D3 TYPING TEST SYSTEM is an FDA 510(k)-cleared medical device (K091753) manufactured by Diagnostic Hybrids, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 27, 2009. Regulation: 8.