
Bio-Rad Laboratories, Inc.
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ACCESS TOTAL BHCG ASSAY (MODIFICATION) is an FDA 510(k)-cleared medical device (K954732) manufactured by Bio-Rad Laboratories, Inc.. 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 November 19, 1995. Regulation: 8.