FDA product code QWZ

Prognostic Test For Assessment Of Chronic Kidney Disease Progression

Clinical Chemistry·Class 2·21 CFR 862.1223
US regulatory classifications
US Product Code (FDA)
QWZ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 862.1223
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A prognostic test for assessment of chronic kidney disease progression is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product.

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About this record

Prognostic Test For Assessment Of Chronic Kidney Disease Progression is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.