DEVICE: Uni-Gold™ (05391516746113)

Device Identifier (DI) Information

Uni-Gold™
1206530
In Commercial Distribution
1206530
TRINITY BIOTECH PUBLIC LIMITED COMPANY
05391516746113
GS1

1
988298840 *Terms of Use
Uni-Gold™ Recombigen® HIV Controls
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
MZF Test, Hiv Detection
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BP030025 003
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 3 x 0.5 mL
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Device Record Status

75298048-7e15-4900-b516-e202affe8377
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+35312769800
HIV@trinitybiotech.com
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