Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516749169
• Version / Model: 40-3022L
• Catalog Number: 40-3022L
• Company Name: MARDX DIAGNOSTICS, INC.
• Labeler DUNS: 154281349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5fd6f8a3-e0f2-46b3-9539-c773b5ede8d6

Device Description

HEp-2 WB IgG Positive Control, 250 µL

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: 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
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	866.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41347	Multiple extractable nuclear antigen (ENA) IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative screening for one or multiple extractable nuclear antigens (ENA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516749169	GS1

Customer Contacts

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

Storage Conditions

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