Uni-Gold™

Basic Information

• Brand Name: Uni-Gold™
• Primary DI: 05391516746113
• Version / Model: 1206530
• Catalog Number: 1206530
• Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY
• Labeler DUNS: 988298840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2021-03-29
• Public Version Status: Update
• Public Device Record Key: 75298048-7e15-4900-b516-e202affe8377
• Distribution End Date: 2020-05-10

Device Description

Uni-Gold™ Recombigen® HIV Controls

Device Characteristics

• Single Use: No
• 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: 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
MZF	Test, Hiv Detection	Microbiology	866.3956	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48456	HIV1/HIV2 antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516746113	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3 x 0.5 mL

Storage Conditions

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