Prognostic Test For Assessment Of Chronic Kidney Disease Progression
QWZ is the FDA product code for Prognostic Test For Assessment Of Chronic Kidney Disease Progression, a class II device type, regulated under 21 CFR 862.1223. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- QWZ
- Device name
- Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- 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.
- Regulation
- 21 CFR 862.1223
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 3
Clearances, product code QWZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
Applicants with the most clearances
Product code QWZ| Applicant | Clearances |
|---|---|
| Renalytix Ai, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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