Home GUDID 05051700020664 EXENT® HCCA MALDI Matrix Pack
Primary DI 05051700020664
Brand EXENT® HCCA MALDI Matrix Pack
Company THE BINDING SITE GROUP LIMITED
Model IK820
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 OTA Mass Spectrometer For Clinical Multiplex Test Systems
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OTA Mass Spectrometer For Clinical Multiplex Test Systems Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05051700020664 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05051700020664 05051700020664 5051700020664
GMDN Terms# Term, Definition table Term Definition Mass spectrometry analysis specimen preparation kit IVD A collection of reagents and other associated materials intended to be used in the preparation of a previously processed clinical specimen (e.g., nucleic acids, proteins) for mass spectrometry analysis (e.g., electrospray ionization, MALDI-TOF). It typically consists of organic/inorganic compound solutions (e.g., imidazole, ammonium bicarbonate) that may added to a volatile solution (e.g., methanol, acetonitrile, hexane) to enable the specimen to disperse into a fine aerosol, and/or promote ionisation of the analyte. The kit can be used with manual or automated instruments.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 347045614 Device count 1 Premarket exempt true 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05051700020640 EXENT® Diluent 1 THE BINDING SITE GROUP LIMITED OTA 2025-11-27 05051700020657 EXENT® Elution buffer 1 THE BINDING SITE GROUP LIMITED OTA 2025-11-27 05051700020671 EXENT® Mass calibration standard 1 THE BINDING SITE GROUP LIMITED OTA 2025-11-27 05051700020688 EXENT® Disposable MALDI plate pack THE BINDING SITE GROUP LIMITED OTA 2025-11-27 05051700020695 EXENT® Wash solution 1 THE BINDING SITE GROUP LIMITED OTA 2025-11-27 05051700020886 EXENT® Analyser THE BINDING SITE GROUP LIMITED OTA 2025-11-27
bindingsite.com