IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)

IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) is an FDA 510(k)-cleared medical device (K883267) manufactured by Diagnostic Products Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 30, 1988. Regulation: 8.