Prognostic Test For Development Or Progression Of Preeclampsia
The prognostic test for development or progression of preeclampsia (product code QWH) is an in vitro diagnostic device in the Clinical Chemistry specialty (regulation 862.1602) that measures one or more analytes from human samples to aid in risk assessment for the development or progression of preeclampsia. Classified as Class 2, it requires 510(k) clearance. The device is explicitly not intended for the diagnosis of any disease. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWH
- Device Class
- FDA class 2
- Regulation Number
- 862.1602
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.