
Rhigene, Inc.
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RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E is an FDA 510(k)-cleared medical device (K000336) manufactured by Rhigene, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2000. Regulation: 8.