FDA.reportPublic FDA data

Alere Triage®

Primary DI
00899722002788
Brand
Alere Triage®
Company
Alere San Diego, Inc.
Model
97021HS
Catalog number
97021HS
Device description
Alere Triage® Cardiac Panel, TnI
Published
2016-09-21
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
MMIImmunoassay Method, Troponin Subunit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899722002788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899722002788008997220027888997220027880899722002788

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

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00810124273019SureStepTM Urine Test Drug Screen Strip, Buprenorphine (BUP10)DBU-101-a-Sgl2023-12-15
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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
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00810124273149SureStep™ Urine Test E-Z Split Key™ Drug Screen CupDBO-157-01245653390192024-09-17
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00810124273217SureStepTM Urine Test Drug Screen Strip, Methamphetamine (MET 1000)DME-101-a-Sgl2023-12-15
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