FDA.reportPublic FDA data

VIDAS® NEPHROCHECK®

Primary DI
03573026616038
Brand
VIDAS® NEPHROCHECK®
Company
BIOMERIEUX SA
Model
421172-01
Device description
VIDAS NEPHROCHECK 60 TESTS is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the risk assessment for moderate or severe acute kidney injury
Published
2023-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210793000VIDAS NEPHROCHECKBiomérieux SA2022-07-08PIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026616038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026616038035730266160383573026616038

GMDN Terms#

Term, Definition table
TermDefinition
Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials 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, using a fluorescent immunoassay method. 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

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
B0744000160ASTUTE140 Electronic Quality Control (EQC) DeviceBIOMERIEUX SAPIG2016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) KitBIOMERIEUX SAPIG2016-08-12
B0745000110NEPHROCHECK Test Kit BIOMERIEUX SAPIG2016-08-12
B0745000130NEPHROCHECK Liquid Control KitBIOMERIEUX SAPIG2016-08-12
B0745000170ASTUTE140 Meter KitBIOMERIEUX SAPIG2016-08-12