Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516748841
• Version / Model: B1029-70B
• Catalog Number: B1029-70B
• Company Name: MARDX DIAGNOSTICS, INC.
• Labeler DUNS: 154281349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e1665c04-2832-42a3-91b7-d67bf98b7b36

Device Description

Toxi-Titer Diluent, 50 mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: 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
MCB	Antigen, C. Difficile	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50827	Clostridium difficile antigen 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 antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516748841	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K833447	000

Storage Conditions

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