Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516746311
• Version / Model: 40-6020P
• Catalog Number: 40-6020P
• 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: 22b562f5-2b19-4676-88bb-2254c3f0d71d

Device Description

Marblot Bordetella IgG PLUS, Western Blot System for the Detection of IgG Antibodies to Bordetella pertussis, 40 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
GOX	Antigen, B. Pertussis	Microbiology	866.3065	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50533	Bordetella pertussis total antibody IVD, kit, immunoblot	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Bordetella pertussis in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516746311	GS1

Customer Contacts

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

Storage Conditions

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