
Biosearch Medical Products, Inc.
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READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT is an FDA 510(k)-cleared medical device (K902236) manufactured by Biosearch Medical Products, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 13, 1990. Regulation: 8.