
Biotecx Laboratories, Inc.
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RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO is an FDA 510(k)-cleared medical device (K844767) manufactured by Biotecx Laboratories, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 31, 1985. Regulation: 8.