
Bion Ent., Ltd.
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BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM is an FDA 510(k)-cleared medical device (K872845) manufactured by Bion Ent., Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 1987. Regulation: 8.