QWH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prognostic Test For Development Or Progression Of Preeclampsia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1602
- Medical specialty
- Clinical Chemistry
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Elecsys sFlt-1 and Elecsys PlGF (K241453) | Roche Diagnostics | 2025-02-07 |
| B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (DEN220027) | Brahms GmbH, Part of Thermo Fisher Scientific | 2023-05-18 |
Track QWH automatically
Every clearance here is in the API, with alerts when new ones post.