DEVICE: Trinity Biotech (05391516746397)

Device Identifier (DI) Information

Trinity Biotech
31-8010
In Commercial Distribution
31-8010
MARDX DIAGNOSTICS, INC.
05391516746397
GS1

1
154281349 *Terms of Use
FTA-ABS, 10 Well Slides, 10 each pack
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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
Treponema pallidum 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 Treponema pallidum in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
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FDA Product Code

[?]
Product Code Product Code Name
JWL Antigen, Treponema Pallidum For Fta-Abs Test
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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 Record Status

b887c0c2-3c9a-4297-a769-769909e61e5f
March 29, 2018
2
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

[?]
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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