Triage

Basic Information

• Brand Name: Triage
• Primary DI: 30014613338017
• Version / Model: 98100EU
• Catalog Number: 98100EU
• Company Name: QUIDEL CARDIOVASCULAR INC.
• Labeler DUNS: 080890141
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-01
• Public Version: 1
• Public Version Date: 2018-12-03
• Public Version Status: New
• Public Device Record Key: a00b0d69-4d86-48a6-a5a3-7be5c4cd8f4d

Device Description

Triage D-Dimer Test (OUS)

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	30014613338017	GS1

Customer Contacts

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