
Micro Detect, Inc.
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MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM is an FDA 510(k)-cleared medical device (K993971) manufactured by Micro Detect, 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 January 10, 2000. Regulation: 8.