Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516748728
• Version / Model: 41-1020G
• Catalog Number: 41-1020G
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0475b96d-6b17-4146-959e-62a8166bf0c8

Device Description

Liver (IgG) Marblot Strip Test System, Western Blot System for the Detection of IgG Antibody to Liver Antigens, 20 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
NBS	Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53967	Protein electrophoresis IVD, kit, electrophoresis	A collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516748728	GS1

Customer Contacts

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

Storage Conditions

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