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 ID: 00899722002764
• NIH Device Record Key: 196b66f2-c167-42c9-a036-667b6f80617e
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Alere Triage®
• Version Model Number: 94401
• Catalog Number: 94401
• 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

Customer Support Contacts

• Phone: +18773088287
• Email: USproductsupport@alere.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00899722002764 [Primary]

FDA Product Code

• MLK: Thin Layer Chroomatography, Tricyclic Antidepressant Drugs

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-04
• Device Publish Date: 2016-09-20

On-Brand Devices [Alere Triage®]

• 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