
Sorin Biomedica, Fiat, USA, Inc.
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TESTOSTERONE DIRECT RADIOIMMUNOASSAY is an FDA 510(k)-cleared medical device (K841948) manufactured by Sorin Biomedica, Fiat, USA, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 24, 1984. Regulation: 8.