Product code QWH— Clinical Chemistry
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
- Classification name
- Prognostic Test For Development Or Progression Of Preeclampsia
- Device class
- Class 2
- Regulation
- 21 CFR 862.1602
- Advisory panel
- Clinical Chemistry
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QWH
FDA has cleared devices under product code QWH between 2023 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2023
Top applicants under product code QWH
Recent clearances under product code QWH
Data sourced from openFDA. This site is unofficial and independent of the FDA.