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NEPHROCHECK Calibration Verification (Cal Vers) Kit

Primary DI
B0745000090
Brand
NEPHROCHECK Calibration Verification (Cal Vers) Kit
Company
BIOMERIEUX SA
Model
500009
Catalog number
500009
Device description
The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.
Published
2016-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PIGAcute Kidney Injury Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIGAcute Kidney Injury Test SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0745000090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple acute kidney injury (AKI) marker IVD, calibratorA 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05711435000156ProNephro AKI™ (NGAL) Reagent KitBioporto Diagnostics A/SPIG2025-08-28
05711435000248ProNephro AKI™ (NGAL) Reagent Kit Bioporto Diagnostics A/SPIG2024-08-02
05711435000255ProNephro AKI™ (NGAL) Calibrator KitBioporto Diagnostics A/SPIG2024-08-02
05711435000262ProNephro AKI™ (NGAL) Control KitBioporto Diagnostics A/SPIG2024-08-02
03573026616038VIDAS® NEPHROCHECK®BIOMERIEUX SAPIG2023-03-13
B0744000160ASTUTE140 Electronic Quality Control (EQC) DeviceBIOMERIEUX SAPIG2016-08-12
B0745000110NEPHROCHECK Test Kit BIOMERIEUX SAPIG2016-08-12
B0745000130NEPHROCHECK Liquid Control KitBIOMERIEUX SAPIG2016-08-12
B0745000170ASTUTE140 Meter KitBIOMERIEUX SAPIG2016-08-12