DEVICE: Trinity Biotech (05391516747684)
Device Identifier (DI) Information
Trinity Biotech
40-2029L
In Commercial Distribution
40-2029L
MARDX DIAGNOSTICS, INC.
40-2029L
In Commercial Distribution
40-2029L
MARDX DIAGNOSTICS, INC.
B. burgdorferi WB Weakly Reactive IgM Control,120µL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
50566 | Borrelia burgdorferi immunoglobulin M (IgM) antibody 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 immunoglobulin M (IgM) antibodies to Borrelia burgdorferi bacteria in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LSR | Reagent, Borrelia Serological Reagent |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K951709 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8370ba24-070a-4b36-a0fb-41ad2ec16c00
July 06, 2018
3
September 19, 2016
July 06, 2018
3
September 19, 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