Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516748773
• Version / Model: 1206630
• Catalog Number: 1206630
• Company Name: MARDX DIAGNOSTICS, INC.
• Labeler DUNS: 154281349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-18
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 95bee479-ef05-4a9e-ace8-baa636256007

Device Description

Uni-Gold™ C. difficile Toxin A/B, 20 Tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50830	Clostridium difficile toxin A/B antigen IVD, kit, agglutination, rapid	A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of toxin A and/or toxin B antigens from Clostridium difficile bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an agglutination method. This test is commonly used in the laboratory or in point-of-care analyses.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516748773	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius