Prognostic Test For Development Or Progression Of Preeclampsia
QWH is the FDA product code for Prognostic Test For Development Or Progression Of Preeclampsia, a class II device type, regulated under 21 CFR 862.1602. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- QWH
- Device name
- Prognostic Test For Development Or Progression Of Preeclampsia
- 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.
- Regulation
- 21 CFR 862.1602
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 1
Clearances, product code QWH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code QWH| Applicant | Clearances |
|---|---|
| Brahms GmbH, Part of Thermo Fisher Scientific | 1 |
| Roche Diagnostics GmbH | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.