
Travenol Laboratories, S.A.
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125I ESTRADIOL DIRECT RADIOIMMUNOASSAY is an FDA 510(k)-cleared medical device (K853208) manufactured by Travenol Laboratories, S.A.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 18, 1985. Regulation: 8.