The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.
NEPHROCHECK Calibration Verification (Cal Vers) Kit - 500009
Device Description
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).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice 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
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