DEVICE: Trinity Biotech (05391516748179)

Device Identifier (DI) Information

Trinity Biotech
Ultra2 Resolution Variants Analyzer
In Commercial Distribution
03-01-0053
PRIMUS CORPORATION
05391516748179
GS1

1
790074793 *Terms of Use
Hemoglobin variants assay, Ultra2 Resolution Variants Analyzer
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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
Inherited haemoglobinopathy IVD, kit, liquid chromatography A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia, using a liquid chromatography method.
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FDA Product Code

[?]
Product Code Product Code Name
GKA Abnormal Hemoglobin Quantitation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K955283 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 2 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

582a40e6-3153-4ae7-85e3-0a76c45a6098
July 06, 2018
3
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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