Home GUDID 05391516746151 Trinity Biotech
Primary DI 05391516746151
Brand Trinity Biotech
Company MARDX DIAGNOSTICS, INC.
Model 30-7120
Catalog number 30-7120
Device description Legionella IFA Test System, (L. pneumophila, serogroups 1-6), 120 Tests
Published 2016-09-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391516746151 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391516746151 05391516746151 5391516746151
GMDN Terms# Term, Definition table Term Definition Legionella pneumophila 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 one or multiple serogroups of Legionella pneumophila in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 154281349 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10628429001674 Legionella pneumophila Serogroup 2 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001681 Legionella pneumophila Serogroup 3 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001698 Legionella pneumophila Serogroup 4 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001704 Legionella pneumophila Serogroup 5 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001711 Legionella pneumophila Serogroup 6 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001728 Legionella micdadei DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001735 Phosphate Buffered Saline (pH 7.6) PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001759 Legionella DFA Negative Control PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001766 Prolex Legionella pneumophila Serogroup 2 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001773 Prolex Legionella pneumophila Serogroup 3 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001780 Prolex Legionella pneumophila Serogroup 4 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001797 Prolex Legionella pneumophila Serogroup 5 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001803 Prolex Legionella pneumophila Serogroup 6 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001810 Prolex Legionella micdadei PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001827 Prolex Legionella pneumophila Negative Control Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001834 Legionella pneumophila Serogroup 1 DFA Kit (50 tests) PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001841 Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests) PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001858 Legionella pneumophila Serogroup 7 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001865 Legionella pneumophila Serogroup 8 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001872 Legionella pneumophila Serogroup 9 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001889 Legionella pneumophila Serogroup 10 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001896 Legionella pneumophila Serogroup 11 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001902 Legionella pneumophila Serogroup 12 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001919 Legionella pneumophila Serogroup 13 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001926 Legionella pneumophila Serogroup 14 DFA Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429001933 Legionella pneumophila Positive Control Serogroups 1-14 PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002015 Prolex Legionella pneumophila Serogroup 7 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002022 Prolex Legionella pneumophila Serogroup 8 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002039 Prolex Legionella pneumophila Serogroup 9 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25 10628429002046 Prolex Legionella pneumophila Serogroup 10 Latex Reagent PRO-LAB, INCORPORATED LHL 2022-12-25
trinitybiotech.com