DEVICE: Trinity Biotech (05391516748636)
Device Identifier (DI) Information
Trinity Biotech
PDQ Wash Reagent
In Commercial Distribution
01-03-0067
PRIMUS CORPORATION
PDQ Wash Reagent
In Commercial Distribution
01-03-0067
PRIMUS CORPORATION
Hemoglobin A1c assay, PDQ Wash Reagent
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
53316 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LCP | Assay, Glycosylated Hemoglobin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K891235 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 28 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 940 Milliliter |
Device Record Status
f6aa89ce-de6b-4ccb-b7b1-fb72bbe9737b
July 06, 2018
3
September 06, 2016
July 06, 2018
3
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
customerservic@trinityusa.com
customerservic@trinityusa.com