
Siemens Healthcare Diagnostics, Inc.
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IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL is an FDA 510(k)-cleared medical device (K141772) 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 18, 2014. Regulation: 8.