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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prognostic test for assessment of chronic kidney disease progression
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.
Product CodeQWZ
Regulation Number 862.1223
Device Class 2


Premarket Reviews
ManufacturerDecision
RENALYTIX AI, INC.
  GRANTED 1

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