
Reagents Applications, Inc.
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RAICHEM(TM) BILIRUBIN STANDARD is an FDA 510(k)-cleared medical device (K882726) manufactured by Reagents Applications, 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 August 28, 1988. Regulation: 8.