Alere Triage® 97000HS

GUDID 00893038002197

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Primary Device ID	00893038002197
NIH Device Record Key	bd5271cd-0f15-4e0d-8dd7-b2d4cf6c763c
Commercial Distribution Discontinuation	2017-10-03
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Alere Triage®
Version Model Number	97000HS
Catalog Number	97000HS
Company DUNS	194854949
Company Name	ALERE SAN DIEGO, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00893038002197 [Primary]

DDR	Myoglobin, Antigen, Antiserum, Control

Steralize Prior To Use	false
Device Is Sterile	false

00899722002764	Alere Triage® TOX Drug Screen – 10 Tests
00893038002104	Alere Triage® Drugs of Abuse Panel Plus TCA
00893038002098	Alere Triage® 8 Panel for Drugs of Abuse
00899722002856	Alere Triage® TOX Drug Screen – 7 Tests
00899722002795	Alere Triage® Cardiac Panel, CK-MB and TnI
00899722002788	Alere Triage® Cardiac Panel, TnI
00899722002771	Alere Triage® TOX Drug Screen – 9 Tests
00899722002757	Alere Triage® TOX Drug Screen
00899722002740	Alere Triage® Profiler SOB™ Panel
00899722002733	Alere Triage® D-Dimer Test
00899722002719	Alere Triage® Cardiac Panel
00899722002702	Alere Triage® BNP Test
00899722002177	Alere Triage® NT-proBNP Test
00899722002078	Alere Triage® PlGF Test
00893038002821	Alere Triage® Troponin I Test
00893038002814	Alere Triage® Cardio2 Panel
00893038002807	Alere Triage® Cardio3 Panel
00893038002388	Alere Triage® BNP Calibrators
00893038002371	Alere Triage® BNP QC Controls
00893038002364	Alere Triage® BNP Reagent Packs
00893038002326	Alere Triage® D-Dimer Test
00893038002289	Alere Triage® BNP Test
00893038002197	Alere Triage® Cardiac Panel
00893038002135	Alere Triage® TOX Drug Screen