1 device · 1 company · 2023
Product code QWZ: Prognostic Test For Assessment Of Chronic Kidney Disease Progression
1 device under product code QWZ, 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Prognostic Test For Assessment Of Chronic Kidney Disease Progression. 21 CFR 862.1223, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| KidneyIntelX.dkdDEN200052 · De Novo | Renalytix AI, Inc. | Clinical Chemistry | database entry |
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