Home GUDID 05391516747585 Trinity Biotech
Primary DI 05391516747585
Brand Trinity Biotech
Company MARDX DIAGNOSTICS, INC.
Model 90-1607
Catalog number 90-1607
Device description Phosphate Buffered Saline, 10g
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 LOO Reagent, Leishmanii Serological LSR Reagent, Borrelia Serological Reagent MIV Immunofluorescent Assay, T. Cruzi MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) NUK For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System NUL For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent Microbiology 2 LOO Reagent, Leishmanii Serological Microbiology 1 LSR Reagent, Borrelia Serological Reagent Microbiology 2 MIV Immunofluorescent Assay, T. Cruzi Microbiology 1 MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) Immunology 2 NUK For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System Unknown N NUL For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System Unknown N
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391516747585 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391516747585 05391516747585 5391516747585
GMDN Terms# Term, Definition table Term Definition 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.
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 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 00845533002950 Anti-Borrelia VlsE1/pepC10 IgG/IgM ZEUS SCIENTIFIC, INC. LSR 2026-02-18 00845533002028 Glomerular Basement Membrane (Primate Kidney) ZEUS SCIENTIFIC, INC. MVJ 2025-10-17 00850049545259 AccuDiag ™ Diagnostic Automation, Inc. LSR 2024-03-06 00850054026378 QMedix™ Diagnostic Automation, Inc. LSR 2024-01-31 04048474028096 B. burgdorferi IgG/IgM ELISA DRG Instruments Gesellschaft mit beschränkter Haftung LSR 2023-08-29 04048474028102 Borrelia burgdorferi IgG (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter Haftung LSR 2023-08-29 04048474028119 Borrelia burgdorferi IgM (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter Haftung LSR 2023-08-29 00840239028099 B. burgdorferi IgG/IgM ELISA DRG International Inc LSR 2023-08-24 00840239028105 Borrelia burgdorferi IgG (Lyme) ELISA DRG International Inc LSR 2023-08-24 00840239028112 Borrelia burgdorferi IgM (Lyme) ELISA DRG International Inc LSR 2023-08-24 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
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