
Primus Corp.
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PRIMUS RAPID GEL 100 GLYCATED HEMOGLOBIN ASSAY is an FDA 510(k)-cleared medical device (K942009) manufactured by Primus Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 1994. Regulation: 8.