Home GUDID 05051700021050 Immunoglobulin Isotypes (GAM) for the EXENT Analyser
Primary DI 05051700021050
Brand Immunoglobulin Isotypes (GAM) for the EXENT Analyser
Company THE BINDING SITE GROUP LIMITED
Model MSR801.M.A
Published 2025-11-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name SGG Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SGG Mass Spectrometric, Immunoglobulins (G, A, M, D, E) Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05051700021050 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05051700021050 05051700021050 5051700021050
GMDN Terms# Term, Definition table Term Definition Multiple monoclonal immunoglobulin isotype IVD, kit, mass spectrometric immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple monoclonal immunoglobulin isotypes including IgA, IgG, IgM, and may also include kappa and lambda light chains, in a clinical specimen, using a mass spectrometric immunoassay method. It is typically used to aid in the diagnosis and monitoring of monoclonal gammopathies such as multiple myeloma, Waldenström's disease, and macroglobulinaemia.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 347045614 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05051700021104 Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems LK016.CB.A 2026-02-02 05051700021111 Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems LK018.CB.A 2026-02-02 05051700006316 Freelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P LK016.H 2016-09-24 05051700006323 Freelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800 LK016.IM 2016-09-24 05051700006439 Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P LK018.H 2016-09-24 05051700010269 Total Haemolytic Complement RC001.1 2016-09-24 05051700010276 Total Haemolytic Complement RC001.2 2016-09-24 05051700010283 Total Haemolytic Complement RC001.3 2016-09-24 05051700010399 Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk Kit RK021 2016-09-24 05051700010504 Human C1 Inactivator BINDARID™ Radial Immunodiffusion Kit RN019.3 2016-09-24 05051700010559 Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion Kit RN025.3 2016-09-24 05051700010764 Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion Kit RN065.3 2016-09-24 05051700010917 Human IgG1 Subclass Single Dilution BINDARID™ Kits RN106.3 2016-09-24 05051700010924 Human IgG2 Subclass Single Dilution BINDARID™ Kits RN107.3 2016-09-24 05051700010931 Human IgG3 Subclass Single Dilution BINDARID™ Kits RN108.3 2016-09-24 05051700010948 Human IgG3 Subclass Single Dilution BINDARID™ Kits RN109.3 2016-09-24 05051700016919 Hevylite® Human IgA Kappa Kit for use on the Siemens BN™II NK623.T.A 2016-09-24 05051700016926 Hevylite IgA Lambda Kit for Siemens BNII NK624.T.A 2016-09-24 05051700018715 Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™ NQ018.IM 2017-06-05 05051700018739 Freelite® Human Kappa Free Control Pack For use on the Beckman Coulter IMMAGE™/ NQ016.IM 2017-06-05
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