Alere Triage®

Basic Information

• Brand Name: Alere Triage®
• Primary DI: 00893038002388
• Version / Model: 98202
• Catalog Number: 98202
• 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: 30cfc95e-e664-4047-9b3c-4c23f5c2bc81
• Distribution End Date: 2017-10-03

Device Description

Alere Triage® BNP Calibrators

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
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47353	B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00893038002388	GS1

Customer Contacts

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