The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.

The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.
NEPHROCHECK Calibration Verification (Cal Vers) Kit - 500009

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple antigens or markers associated with acute kidney injury (AKI) in a clinical specimen. The range of analytes detected may include (but is not limited to) insulin-like growth factor-binding protein 7 (IGFBP-7), neutrophil gelatinase-associated lipocalin (NGAL), tissue-inhibitor of metalloproteinase-2 (TIMP-2), cystatin C, kidney injury molecule-1 (Kim-1) and/or L-type fatty acid–binding protein (L-FABP).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PIG

Device Name: Acute Kidney Injury Test System

Device Class: 2

Physical State: The test system may include clinical analyzers, reagents, calibrators, and controls.

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.

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Assay to measure analyte(s) that are markers of Acute Kidney Injury

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The test system is an in vitro diagnostic device that measures human samples.

Regulation Number: 862.1220

Third Party Flag: N

Medical Specialty: CH

Device Id: B0745000090

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A