FDA.reportPublic FDA data

Triage

Primary DI
30014613337164
Brand
Triage
Company
QUIDEL CARDIOVASCULAR INC.
Model
55071
Catalog number
55071
Device description
Triage MeterPro, International
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
DDRMYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
JHXFLUOROMETRIC METHOD, CPK OR ISOENZYMES
KHOFLUOROMETER, FOR CLINICAL USE
MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDRMyoglobin, Antigen, Antiserum, ControlImmunology2
JHXFluorometric Method, Cpk Or IsoenzymesClinical Chemistry2
KHOFluorometer, For Clinical UseClinical Chemistry1
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30014613337164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3001461333716430014613337164

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, point-of-care, battery-poweredA portable, battery-powered instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative, and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)552-1102technicalsupport@quidel.com
+1(858)552-1100technicalsupport@quidel.com

Regulatory Flags#

DUNS number
080890141
Device count
1
Kit
true
Serial number
true
Manufacturing 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
30014613337997Triage98000XREU98000XREU2018-11-01
30014613338017Triage98100EU98100EU2018-11-01
30014613338024Triage98600EU98600EU2018-11-01
30014613338109Triage94600946002019-08-02
30014613338116Triage94613946132019-07-24
30014613338123Triage94614946142019-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076346010HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
10850076346017HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
05430003908761SEEKER®Lacar MDX TechnologiesKHO2026-01-15
10758750033522VITROSORTHO CLINICAL DIAGNOSTICSMMI2025-12-30
10054749003058i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
00054749003051i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
07649996894014abioSCOPEAbionic SAKHO2025-02-18
06974849369380Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
06974849369397Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
08809317541259FREND SystemNanoEnTek, Inc.KHO2024-06-30
04987595301803PATHFAST hs-cTnI-IIPHC CORPORATIONMMI2024-05-01
15099590781521Access CK-MBBeckman Coulter, Inc.JHX2024-03-01
08800066300104ASFA® SCANNERMBD CO., Ltd.KHO2023-11-21
06974521002246Superbio Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
06974521006626Bioeasy Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCAROLINA LIQUID CHEMISTRIES CORPORATIONKHO2023-03-10
06974849369298Immunofluorescence ReaderJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2022-12-06
10758750034314VITROSORTHO CLINICAL DIAGNOSTICSJHX2022-10-24
06438147335008AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
06438147335022AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
00380740194062AlinityABBOTT IRELANDMMI2022-07-08
00380740194079AlinityABBOTT IRELANDMMI2022-07-08
07613336158951Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2022-03-01
07613336158982Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2021-09-23
00894175000466RapiCard™ InstaTestDiagnostic Automation, Inc.MMI2021-08-27
09120052070521INFINITE 200 PROTecan Austria GmbHKHO2021-06-22
04897078440045ALiA FIA AnalyserSANWA BIOTECH LIMITEDKHO2021-01-27
04897078440052Ariel Fluorescent Immunoassay SystemSANWA BIOTECH LIMITEDKHO2021-01-27
04897078440106Thetis Fluorescent Immunoassay SystemSANWA BIOTECH LIMITEDKHO2021-01-27
30014613336341SofiaQUIDEL CORPORATIONKHO2020-10-21