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
05391516748070
GS1

1
790074793 *Terms of Use
Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JPK Mixture, Hematology Quality Control
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112015 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

573eebaf-c2d2-49af-b5a2-0554c95e2feb
August 29, 2022
5
September 06, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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