
Siemens Healthcare Diagnostics, Inc.
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IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material is an FDA 510(k)-cleared medical device (K143352) 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 December 23, 2014. Regulation: 8.