AccessGUDID - DEVICE: Trinity Biotech (05391516747622)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: 40-2023L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40-2023L
Company Name: MARDX DIAGNOSTICS, INC.

Primary DI Number: 05391516747622
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154281349 *Terms of Use

Device Description: B. burgdorferi WB IgG Serum Band Locator, 250µL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Legionella pneumophila 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 serogroups of Legionella pneumophila in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.

GMDN Preferred Term Name

GMDN Definition

Legionella pneumophila 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 serogroups of Legionella pneumophila in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.

FDA Product Code

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Product Code	Product Code Name
LSR	Reagent, Borrelia Serological Reagent

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 34785fa2-033d-4eee-b504-371698a41fef
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016