
Biotrax, Inc.
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CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST is an FDA 510(k)-cleared medical device (K904498) manufactured by Biotrax, 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 October 28, 1990. Regulation: 8.