Uni-Gold™ 1206506

GUDID 05391516746106

Uni-Gold™ Recombigen® HIV-1/2

TRINITY BIOTECH PUBLIC LIMITED COMPANY

HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 05391516746106
• NIH Device Record Key: f1ce2926-ea89-49c5-80c6-b29ebaaf2a2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni-Gold™
• Version Model Number: 1206506
• Catalog Number: 1206506
• Company DUNS: 988298840
• Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com
• Phone: +35312769800
• Email: HIV@trinitybiotech.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391516746106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP030025

FDA Product Code

• MZF: Test, Hiv Detection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Uni-Gold™ ]

• 05391516746113: Uni-Gold™ Recombigen® HIV Controls
• 05391516746106: Uni-Gold™ Recombigen® HIV-1/2