
Biostar Medical Products, Inc.
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QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA is an FDA 510(k)-cleared medical device (K893896) 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 July 13, 1989. Regulation: 8.