DEVICE: Trinity Biotech (05391516747721)

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Device Identifier (DI) Information

Trinity Biotech
40-1013
40-1013
MARDX DIAGNOSTICS, INC.
05391516747721
GS1
1
10x Wash Solution, 100 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
Bordetella pertussis immunoglobulin A (IgA)/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 A (IgA), immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to Bordetella pertussis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.
Borrelia burgdorferi immunoglobulin G (IgG) 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) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.
Helicobacter pylori immunoglobulin M (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 M (IgM) antibodies to Helicobacter pylori bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.
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FDA Product Code

[?]
Product Code Product Code Name
LSR Reagent, Borrelia Serological Reagent
LYR Helicobacter Pylori
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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

[?]
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

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

[?]
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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