
Siemens Healthcare Diagnostics, Inc.
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ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG is an FDA 510(k)-cleared medical device (K191533) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 27, 2019. Regulation: 8.