Home GUDID 00840239056450 Legionella pneumophila IgG ELISA
Primary DI 00840239056450
Brand Legionella pneumophila IgG ELISA
Company DRG International Inc
Model EIA-5645
Catalog number EIA-5645
Device description The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
Published 2023-08-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MJH Legionella, Spp., Elisa
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MJH Legionella, Spp., Elisa Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840239056450 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840239056450 00840239056450 840239056450 0840239056450
GMDN Terms# Term, Definition table Term Definition Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to one or multiple serogroups of Legionella pneumophila bacteria in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 075150847 Device count 1 Premarket exempt true Kit true Lot or batch true Manufacturing date on label 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 05032384013227 LEGIONELLA SPECIES TEST KIT OXOID LIMITED MJH 2022-12-08 05713106105573 ImmuView S. pneumoniae and L. pneumophila urinary antigen test Ssi Diagnostica A/S MJH 2022-10-25 05713106024515 ImmuView S. pneumoniae and L. pneumophila urinary antigen test Ssi Diagnostica A/S MJH 2020-03-24 05391516746670 Bartels CLARK LABORATORIES, INC. MJH 2019-11-06 10811877011054 BinaxNOW™ Legionella Control Swab Pack Alere Scarborough, Inc. MJH 2019-07-15 10811877011023 BinaxNOW Legionella Urinary Antigen Card Alere Scarborough, Inc. MJH 2019-07-08 04048474056457 Legionella pneumophila IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung MJH 2019-06-10 00404847456455 Legionella pneumophila IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung MJH 2019-06-10 04049016027508 Anti-Legionella pneumophila ELISA (IgA) EUROIMMUN Medizinische Labordiagnostika AG MJH 2016-09-24 04049016027515 Anti-Legionella pneumophila ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG MJH 2016-09-24 04049016027522 Anti-Legionella pneumophila ELISA (IgM) EUROIMMUN Medizinische Labordiagnostika AG MJH 2016-09-24 05032384013197 NA OXOID LIMITED MJH 2016-09-24 05032384013203 NA OXOID LIMITED MJH 2016-09-24 05032384013210 NA OXOID LIMITED MJH 2016-09-24 05032384060535 NA OXOID LIMITED MJH 2016-09-24 05032384060542 NA OXOID LIMITED MJH 2016-09-24 05032384061365 NA OXOID LIMITED MJH 2016-09-24 00840733101267 TRU Legionella MERIDIAN BIOSCIENCE, INC. MJH 2016-09-23 05391516744065 Trinity Biotech CLARK LABORATORIES, INC. MJH 2016-09-23 05391516747202 Trinity Biotech CLARK LABORATORIES, INC. MJH 2016-09-19 10811877010460 Binax® Legionella Urinary Antigen EIA Alere Scarborough, Inc. MJH 2016-09-03 10811877010767 Binax® Legionella EIA Wash Buffer Accessory Kit Alere Scarborough, Inc. MJH 2016-09-03 10811877010491 Alere™ BinaxNOW® Legionella Control Swab Kit Alere Scarborough, Inc. MJH 2016-09-01 10811877010477 Alere™ BinaxNOW® Legionella Urinary Antigen Card Alere Scarborough, Inc. MJH 2016-09-01
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