Product code PIG

Device name

Acute Kidney Injury Test System

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1220

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset