FDA.reportPublic FDA data

VIDAS® NT-proBNP

Primary DI
03573026231453
Brand
VIDAS® NT-proBNP
Company
BIOMERIEUX SA
Model
30449-01
Device description
VIDAS ® NT- proBNP is a quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B- type natriuretic peptide in serum/plasma.
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NBCTest,Natriuretic Peptide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBCTest, Natriuretic PeptideClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026231453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026231453035730262314533573026231453

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

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
15099590786533Access BNP IIBeckman Coulter, Inc.NBC2026-03-30
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)AXIS-SHIELD DIAGNOSTICS LIMITEDNBC2025-02-26
15099590760823Access NT-proBNPBeckman Coulter, Inc.NBC2024-04-19
07613336217689Elecsys ProBNP IIRoche Diagnostics GmbHNBC2024-02-19
00630414284927ADVIA Centaur PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284934ADVIA Centaur PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284941Atellica IM PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284958Atellica IM PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
07613336191521Elecsys proBNP II ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336191569Elecsys proBNP II ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336191576Elecsys proBNP II STAT ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
10758750033300VITROSORTHO CLINICAL DIAGNOSTICSNBC2021-11-08
15099590750947Access BNP Beckman Coulter, Inc.NBC2021-08-18
14560189212876ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
04560189212879ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
00630414293462Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00630414294032Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00380740145279ARCHITECTAbbott GmbHNBC2019-01-21
00380740145286ARCHITECTAbbott GmbHNBC2019-01-21
30014613337706TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337973TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337980TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337997TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613338031TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
00630414597980Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2017-12-22
00630414597997Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2017-12-22
00630414598024Atellica IM BNP QCSiemens Healthcare Diagnostics Inc.NBC2017-12-22
04015630939756Elecsys proBNP IIRoche Diagnostics GmbHNBC2017-04-21