DEVICE: Trinity Biotech (05391516747943)

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Device Identifier (DI) Information

Trinity Biotech
90-1610
90-1610
MARDX DIAGNOSTICS, INC.
05391516747943
GS1
1
FITC Mounting Medium (pH 7.5), 3.0 mL
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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
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.
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.
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, 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 species of the parasitic protozoan Leishmania in a clinical specimen, using a fluorescent immunoassay method.
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FDA Product Code

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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
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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 19, 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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