Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516747943
• Version / Model: 90-1610
• Catalog Number: 90-1610
• Company Name: MARDX DIAGNOSTICS, INC.
• Labeler DUNS: 154281349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 72f5744e-b88d-42d2-bbae-c65f2b1f9e06

Device Description

FITC Mounting Medium (pH 7.5), 3.0 mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LEB	Mounting Media	Pathology	864.4010	1
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	Immunology	866.5660	2
NUK	For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System	Unknown		N
MIV	Immunofluorescent Assay, T. Cruzi	Microbiology	866.3870	1
NUL	For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System	Unknown		N
LOO	Reagent, Leishmanii Serological	Microbiology	866.3870	1
LSR	Reagent, Borrelia Serological Reagent	Microbiology	866.3830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
54951	Glomerular basement membrane antibody (Goodpasture 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 glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen, using a fluorescent immunoassay method.	No	Active
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.	No	Active
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.	No	Active
52281	Multiple Leishmania species 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 multiple species of the parasitic protozoan Leishmania in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516747943	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius