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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prognostic test for development or progression of preeclampsia
Definition A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease.
Product CodeQWH
Regulation Number 862.1602
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAHMS GMBH, PART OF THERMO FISHER SCIENTIFIC
  GRANTED 1

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