FDA.reportPublic FDA data

Triage

Primary DI
30014613337959
Brand
Triage
Company
QUIDEL CARDIOVASCULAR INC.
Model
97300EU
Catalog number
97300EU
Device description
Triage Profiler SOB Panel (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
DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL
DDRMYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
JHXFLUOROMETRIC METHOD, CPK OR ISOENZYMES
MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT
NBCTEST,NATRIURETIC PEPTIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlHematology2
DDRMyoglobin, Antigen, Antiserum, ControlImmunology2
JHXFluorometric Method, Cpk Or IsoenzymesClinical Chemistry2
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2
NBCTest, Natriuretic PeptideClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613337959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333795930014613337959

GMDN Terms#

Term, Definition table
TermDefinition
Multiple cardiac marker IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using a fluorescent immunoassay method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1129technicalsupport@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
30014613337966Triage97400EU97400EU2018-11-01
30014613337973Triage97500EU97500EU2018-11-01
30014613337997Triage98000XREU98000XREU2018-11-01
30014613338017Triage98100EU98100EU2018-11-01
30014613338024Triage98600EU98600EU2018-11-01
30014613338109Triage94600946002019-08-02
30014613338116Triage94613946132019-07-24
30014613338123Triage94614946142019-07-24
30014613337010Triage98013XR98013XR2018-11-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10054749003058i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
00054749003051i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)AXIS-SHIELD DIAGNOSTICS LIMITEDNBC2025-02-26
00816870023878D-Dimer AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023885D-Dimer AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00816870023892D-Dimer AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023908D-Dimer AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
04987595301803PATHFAST hs-cTnI-IIPHC CORPORATIONMMI2024-05-01
15099590760823Access NT-proBNPBeckman Coulter, Inc.NBC2024-04-19
00630414639666INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00842768019265INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640181INNOVANCE D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640488INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640501INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
15099590781521Access CK-MBBeckman Coulter, Inc.JHX2024-03-01
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
10758750034314VITROSORTHO CLINICAL DIAGNOSTICSJHX2022-10-24
00380740194062AlinityABBOTT IRELANDMMI2022-07-08
00380740194079AlinityABBOTT IRELANDMMI2022-07-08
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
07613336158951Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2022-03-01
10758750033300VITROSORTHO CLINICAL DIAGNOSTICSNBC2021-11-08