DEVICE: Trinity Biotech (05391516747943)
Device Identifier (DI) Information
Trinity Biotech
90-1610
In Commercial Distribution
90-1610
MARDX DIAGNOSTICS, INC.
90-1610
In Commercial Distribution
90-1610
MARDX DIAGNOSTICS, INC.
FITC Mounting Medium (pH 7.5), 3.0 mL
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? |
---|---|---|---|---|
50555 | Borrelia burgdorferi total antibody IVD, kit, immunoblot |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.
|
Active | false |
54951 | Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
55134 | Skeletal muscle antibody IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to skeletal muscle in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
52495 | Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to the parasitic protozoan Trypanosoma cruzi in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
52281 | Multiple Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to multiple species of the parasitic protozoan Leishmania in a clinical specimen, using a fluorescent immunoassay method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LEB | Mounting Media |
MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) |
NUK | For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System |
MIV | Immunofluorescent Assay, T. Cruzi |
NUL | For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System |
LOO | Reagent, Leishmanii Serological |
LSR | Reagent, Borrelia Serological Reagent |
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 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
72f5744e-b88d-42d2-bbae-c65f2b1f9e06
June 02, 2023
3
September 19, 2016
June 02, 2023
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 |
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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