TriniLIA™ D-Dimer

Basic Information

• Brand Name: TriniLIA™ D-Dimer
• Primary DI: 05391521420572
• Version / Model: T3101
• Company Name: TCOAG IRELAND LIMITED
• Labeler DUNS: 985039126
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 115df50d-f455-4b5b-870c-c9f331e2086f

Device Characteristics

• Single Use: No
• 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
47346	D-dimer IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391521420572	GS1

Premarket Submissions

Submission Number	Supplement Number
K003267	000

Storage Conditions

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