Alere Triage® 94401

GUDID 00899722002764

Alere Triage® TOX Drug Screen – 10 Tests

ALERE SAN DIEGO, INC.

Multiple drugs of abuse IVD, kit, fluorescent immunoassay
Primary Device ID00899722002764
NIH Device Record Key196b66f2-c167-42c9-a036-667b6f80617e
Commercial Distribution Discontinuation2018-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAlere Triage®
Version Model Number94401
Catalog Number94401
Company DUNS194854949
Company NameALERE SAN DIEGO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18773088287
EmailUSproductsupport@alere.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100899722002764 [Primary]

FDA Product Code

MLKThin Layer Chroomatography, Tricyclic Antidepressant Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-04
Device Publish Date2016-09-20

On-Brand Devices [Alere Triage®]

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

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