Alere Triage® 94402

GUDID 00899722002771

Alere Triage® TOX Drug Screen – 9 Tests

ALERE SAN DIEGO, INC.

Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay Multiple drugs of abuse IVD, kit, fluorescent immunoassay

• Primary Device ID: 00899722002771
• NIH Device Record Key: cf940a11-f4f1-4877-b13f-bfb68eb3b2de
• Commercial Distribution Discontinuation: 2017-10-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Alere Triage®
• Version Model Number: 94402
• Catalog Number: 94402
• 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
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com
• Phone: +18773088287
• Email: USproductsupport@alere.com

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00899722002771 [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: 2023-08-23
• 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