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Prognostic Test For Development Or Progression Of Preeclampsia

FDA product code QWH · 1 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1602
Review panel
TX
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-02-07 – 2025-02-07

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.

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