Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516748001
• Version / Model: 10-5648
• Catalog Number: 10-5648
• 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: 15da87b0-ab22-4fa1-b531-cdb0db206b3c

Device Description

Glomerular Basement Membrane IFA Test System, 48 Tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54951	Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516748001	GS1

Customer Contacts

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

Storage Conditions

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