
Amtec Diagnostics International, Inc.
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ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST is an FDA 510(k)-cleared medical device (K882998) manufactured by Amtec Diagnostics International, 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 September 6, 1988. Regulation: 8.