FDA.reportPublic FDA data

Triage

Primary DI
30014613337997
Brand
Triage
Company
QUIDEL CARDIOVASCULAR INC.
Model
98000XREU
Catalog number
98000XREU
Device description
Triage BNP Test (OUS)
Published
2018-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
30014613337997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333799730014613337997

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassayA 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 a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1133technicalsupport@quidel.com

Regulatory Flags#

DUNS number
080890141
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30014613337706Triage98200982002018-11-01
30014613337911Triage97000HS97000HS2018-11-01
30014613337935Triage97021HS97021HS2018-11-01
30014613337942Triage97022HS97022HS2018-11-01
30014613337980Triage98000XR98000XR2018-11-01
30014613338000Triage98100981002018-11-01
30014613338772Sofia20352203522025-11-18
50014613338776Sofia20352203522025-11-18
30014613337041Triage98713EU98713EU2018-11-07
30014613337713Triage98201982012018-11-01
30014613337720Triage98202982022018-11-01
30014613337959Triage97300EU97300EU2018-11-01
30014613337966Triage97400EU97400EU2018-11-01
30014613337973Triage97500EU97500EU2018-11-01
30014613338017Triage98100EU98100EU2018-11-01
30014613338024Triage98600EU98600EU2018-11-01
30014613338109Triage94600946002019-08-02
30014613338116Triage94613946132019-07-24
30014613338123Triage94614946142019-07-24
30014613337010Triage98013XR98013XR2018-11-01

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
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
00895160002434Fluoro-CheckTM NT-proBNPNANO-DITECH CORPORATIONNBC2016-10-05