DEVICE: Trinity Biotech (05391516746182)

Download: XML | JSON

Device Identifier (DI) Information

Trinity Biotech
32-5100G
32-5100G
MARDX DIAGNOSTICS, INC.
05391516746182
GS1
1
Lyme Disease IgG IFA Test System (100 Tests)
CLOSE

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
Multiple Borrelia species immunoglobulin A (IgA)/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 A (IgA), immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to one or multiple species of Borrelia in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Borrelia bacteria which may include B. afzelii, B. burgdorferi and/or B. garinii that are associated with Lyme disease.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LSR Reagent, Borrelia Serological Reagent
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 18, 2016

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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