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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device acute kidney injury test system
Definition An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods.
Product CodePIG
Regulation Number 862.1220
Device Class 2

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