DEVICE: Trinity Biotech (05391516748063)

Device Identifier (DI) Information

Trinity Biotech
Premier Hb9210 HbA1c Analytical Column (500)
In Commercial Distribution
09-06-0050
PRIMUS CORPORATION
05391516748063
GS1

1
790074793 *Terms of Use
Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (500)
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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
Glycated haemoglobin (HbA1c) 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 detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
LCP Assay, Glycosylated Hemoglobin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112015 000
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
No Device Sizes
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Device Record Status

9cd065b9-c6a9-4489-9228-214375642fdf
July 06, 2018
3
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
Yes
Yes
Yes
No CLOSE

Customer Contact

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