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Acute Kidney Injury Test System

FDA product code PIG · 4 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1220
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-06-01 – 2023-12-07

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.

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