AccessGUDID - DEVICE: Trinity Biotech (05391516747585)

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Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: 90-1607
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90-1607
Company Name: MARDX DIAGNOSTICS, INC.

Primary DI Number: 05391516747585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154281349 *Terms of Use

Device Description: Phosphate Buffered Saline, 10g

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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

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
51050	Legionella pneumophila total 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 total 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.	Active	false
55134	Skeletal muscle 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 antibodies to skeletal muscle in a clinical specimen, using a fluorescent immunoassay method.	Active	false
52495	Trypanosoma cruzi immunoglobulin G (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 G (IgG) and immunoglobulin M (IgM) antibodies to the parasitic protozoan Trypanosoma cruzi in a clinical specimen, using a fluorescent immunoassay method.	Active	false
52282	Multiple Leishmania species 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 multiple species of the parasitic protozoan Leishmania in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false
50555	Borrelia burgdorferi total antibody IVD, kit, immunoblot	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.	Active	false
47384	Multiple cardiac marker IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using a fluorescent immunoassay method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.	Active	false

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FDA Product Code

Product Code	Product Code Name
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
NUK	For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
LSR	Reagent, Borrelia Serological Reagent
MIV	Immunofluorescent Assay, T. Cruzi
NUL	For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System
LOO	Reagent, Leishmanii Serological
LHL	Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

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FDA Premarket Submission

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

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

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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

Public Device Record Key: 8f377809-a46e-4844-ab4f-417e3eaf45d7
Public Version Date: June 02, 2023
Public Version Number: 3
DI Record Publish Date: 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)

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
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Production Identifier(s) in UDI

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

Phone: 800-325-3424
Email: info@trinitybiotech.com

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