DEVICE: Trinity Biotech (05391516748803)
Device Identifier (DI) Information
Trinity Biotech
1206641
In Commercial Distribution
1206641
MARDX DIAGNOSTICS, INC.
1206641
In Commercial Distribution
1206641
MARDX DIAGNOSTICS, INC.
Uni-Gold™ C. difficile GDH Controls, 1 Positive and 1 Negative
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
50826 | Clostridium difficile antigen IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MCB | Antigen, C. Difficile |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2c59dbe9-8ef7-4af8-a7c3-407fc867718c
March 29, 2018
2
September 18, 2016
March 29, 2018
2
September 18, 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
info@trinitybiotech.com
info@trinitybiotech.com