DEVICE: Trinity Biotech (05391516748193)

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Device Identifier (DI) Information

Trinity Biotech
Genesys Diluent Reagent - 3.8L
01-03-0019
PRIMUS CORPORATION
05391516748193
GS1
1
Hemoglobin variants assay, Genesys Diluent Reagent - 3.8L
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Multiple haemolobin subtype IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of one or multiple subtypes of haemoglobin in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
GKA Abnormal Hemoglobin Quantitation
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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 28 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 3.8 Liter
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Device Status

In Commercial Distribution
September 06, 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
Yes
No CLOSE

Customer Contact

[?]
800-325-3424
customerservice@trinityusa.com
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