DEVICE: Trinity Biotech (05391516748070)
Device Identifier (DI) Information
Trinity Biotech
HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit
In Commercial Distribution
01-04-0022
PRIMUS CORPORATION
HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit
In Commercial Distribution
01-04-0022
PRIMUS CORPORATION
Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
Yes |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
53315 | Glycated haemoglobin (HbA1c) IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JPK | Mixture, Hematology Quality Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K112015 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
573eebaf-c2d2-49af-b5a2-0554c95e2feb
August 29, 2022
5
September 06, 2016
August 29, 2022
5
September 06, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-325-3424
customerservice@trinityusa.com
customerservice@trinityusa.com