
Biostar Medical Products, Inc.
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BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT is an FDA 510(k)-cleared medical device (K853697) manufactured by Biostar Medical Products, 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 December 15, 1985. Regulation: 8.