DEVICE: Trinity Biotech (05391516746236)

Device Identifier (DI) Information

Trinity Biotech
40-5065G/B
In Commercial Distribution
40-5065G/B
MARDX DIAGNOSTICS, INC.
05391516746236
GS1

1
154281349 *Terms of Use
B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
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 garinii 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 garinii in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Borrelia garinii, the bacteria associated with Lyme disease.
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FDA Product Code

[?]
Product Code Product Code Name
LSR Reagent, Borrelia Serological Reagent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K950829 000
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Sterilization

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

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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 Record Status

09e10bdf-b883-4cf6-8a9f-cafd8289feae
July 06, 2018
3
September 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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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