QWZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1223
- Medical specialty
- Clinical Chemistry
- FDA 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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| Record | Firm | Date |
|---|---|---|
| KidneyIntelX.dkd (DEN200052) | Renalytix Ai, Inc. | 2023-06-29 |
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