
Biochem Immunosystems (U.S.), Inc.
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BIODATA TESTOSTERONE MAIA KIT is an FDA 510(k)-cleared medical device (K955102) manufactured by Biochem Immunosystems (U.S.), Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 23, 1996. Regulation: 8.