Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- US Product Code (FDA)
- QWZView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 862.1223View CFR Regulation →
- Medical specialty
- Clinical Chemistry
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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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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.
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