QWH · Prognostic Test For Development Or Progression Of Preeclampsia
Clinical Chemistry · 21 CFR 862.1602 · Class 2
Overview
| Product Code | QWH |
|---|---|
| Device Name | Prognostic Test For Development Or Progression Of Preeclampsia |
| Regulation | 21 CFR 862.1602 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics | Feb 7, 2025 | SESE |
| DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | Brahms GmbH, Part of Thermo Fisher Scientific | May 18, 2023 | DENG |
Top Applicants
- Brahms GmbH, Part of Thermo Fisher Scientific — 1 clearance
- Roche Diagnostics — 1 clearance
