Triage®

Basic Information

• Brand Name: Triage®
• Primary DI: 00893038002180
• Version / Model: 96100
• Catalog Number: 96100
• 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: 2016-09-21
• Public Version: 3
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: a50c35c1-046c-40b7-998c-d42d75f83a3d
• Distribution End Date: 2017-10-03

Device Description

Triage® Micro Parasite Panel

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
GMO	Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.	Microbiology	866.3220	2
MHJ	Cryptosporidium Spp.	Microbiology	866.3220	2
MHI	Giardia Spp.	Microbiology	866.3220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47356	Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00893038002180	GS1

Customer Contacts

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