DEVICE: Trinity Biotech (05391516747585)

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Device Identifier (DI) Information

Trinity Biotech
90-1607
90-1607
MARDX DIAGNOSTICS, INC.
05391516747585
GS1
1
Phosphate Buffered Saline, 10g
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Legionella pneumophila total 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 total antibodies to one or multiple serogroups of Legionella pneumophila in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.
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.
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.
Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA) 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 species of the parasitic protozoan Leishmania in a clinical specimen, using an enzyme immunoassay (EIA) method.
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.
Multiple cardiac marker IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using a fluorescent immunoassay method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.
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FDA Product Code

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Product Code Product Code Name
MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
NUK For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
LSR Reagent, Borrelia Serological Reagent
MIV Immunofluorescent Assay, T. Cruzi
NUL For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System
LOO Reagent, Leishmanii Serological
LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 18, 2016

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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-325-3424
info@trinitybiotech.com
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