FDA.reportPublic FDA data

Alere Triage®

Primary DI
00893038002807
Brand
Alere Triage®
Company
Alere San Diego, Inc.
Model
97400EU
Catalog number
97400EU
Device description
Alere Triage® Cardio3 Panel
Published
2016-09-26
Public version status
Update
Distribution status
Not 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
JHXFluorometric Method, Cpk Or Isoenzymes
MMIImmunoassay Method, Troponin Subunit
NBCTest,Natriuretic Peptide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHXFluorometric Method, Cpk Or IsoenzymesClinical Chemistry2
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2
NBCTest, Natriuretic PeptideClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893038002807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893038002807008930380028078930380028070893038002807

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18773088287USproductsupport@alere.com

Regulatory Flags#

DUNS number
194854949
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810124272975CERTUM One Step Multi-Line Drug Screen EZ SplitDBO-167-022-a45651613262024-10-10
00810124272982SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 300)DAM-A101-a-Sgl2023-12-15
00810124272999SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 1000)DAM-101-a-Sgl2023-12-15
00810124273002SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)DBA-101-a-Sgl2023-12-15
00810124273019SureStepTM Urine Test Drug Screen Strip, Buprenorphine (BUP10)DBU-101-a-Sgl2023-12-15
00810124273026SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)DBZ-101-a-Sgl2023-12-15
00810124273033SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 150)DCO-U101-a-Sgl2023-12-15
00810124273040SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 500)DME-U101-a-Sgl2023-12-15
00810124273057SureStepTM Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500DMD-101-a-Sgl2023-12-15
00810124273064SureStepTM Urine Test Drug Screen Strip, Opiate (MOP 300)DMO-101-a-Sgl2023-12-15
00810124273071SureStepTM Urine Test Drug Screen Strip, Methadone (MTD 300)DMT-101-a-Sgl2023-12-15
00810124273088SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)DTC-101-a-Sgl2023-12-15
00810124273095SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)DTH-101-a-Sgl2023-12-15
00810124273149SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-157-01245653390192024-09-17
00810124273156SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-167-52145653490192024-09-17
00810124273163SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-02145653590192024-09-17
00810124273170SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-1107-01145653690192024-09-17
00810124273200SureStepTM Urine Test Drug Screen Strip, Cocaine (COC 300)DCO-101-a-Sgl2023-12-15
00810124273217SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)DME-101-a-Sgl2023-12-15
00810124273224SureStepTM Urine Test Drug Screen Strip, Opiate (OPI 2000)DMO-101-a-Sgl2023-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590786533Access BNP IIBeckman Coulter, Inc.NBC2026-03-30
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
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)AXIS-SHIELD DIAGNOSTICS LIMITEDNBC2025-02-26
04987595301803PATHFAST hs-cTnI-IIPHC CORPORATIONMMI2024-05-01
15099590760823Access NT-proBNPBeckman Coulter, Inc.NBC2024-04-19
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
07613336158982Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2021-09-23
00894175000466RapiCard™ InstaTestDiagnostic Automation, Inc.MMI2021-08-27
15099590750947Access BNP Beckman Coulter, Inc.NBC2021-08-18
14560189212876ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
04560189212879ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
00083059070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KITBIOMERICA, INC.MMI2020-07-01
00630414293462Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00630414294032Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00630414293783Atellica IM TNIHSiemens Healthcare Diagnostics Inc.MMI2020-05-31