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Prognostic Test For Development Or Progression Of Preeclampsia

FDA product code QWH · Class 2 · Clinical Chemistry

6
Registered devices
2
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

B.R.A.H.M.S PlGF plus KRYPTOR — B.R.A.H.M.S GmbHElecsys PlGF — Roche Diagnostics GmbHB.R.A.H.M.S sFlt-1 KRYPTOR — B.R.A.H.M.S GmbHElecsys sFlT-1 — Roche Diagnostics GmbHElecsys PlGF — Roche Diagnostics GmbHElecsys sFlT-1 — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2026-03-12Brahms GmbHCustomers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting st

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