Uni-Gold™ 1206530
GUDID 05391516746113
Uni-Gold™ Recombigen® HIV Controls
TRINITY BIOTECH PUBLIC LIMITED COMPANY
HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control HIV1/HIV2 antibody IVD, control| Primary Device ID | 05391516746113 |
| NIH Device Record Key | 75298048-7e15-4900-b516-e202affe8377 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uni-Gold™ |
| Version Model Number | 1206530 |
| Catalog Number | 1206530 |
| 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 | false |
| 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 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| HIV@trinitybiotech.com | |
| Phone | +35312769800 |
| 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 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391516746113 [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 |
Trademark Results [Uni-Gold]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNI-GOLD 74613218 1941014 Live/Registered |
TRINITY BIOTECH INC. 1994-12-20 |
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