Alere Triage®

Basic Information

• Brand Name: Alere Triage®
• Primary DI: 00893038002326
• Version / Model: 98100
• Catalog Number: 98100
• Company Name: ALERE SAN DIEGO, INC.
• Labeler DUNS: 194854949
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: 6be6f1b2-e500-49ea-8ea8-d31a38842499
• Distribution End Date: 2017-10-03

Device Description

Alere Triage® D-Dimer Test

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	864.7320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47349	D-dimer IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00893038002326	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius