126 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Enforcement
Class II
·Terminated·Abbott Gmbh & Co. KG·September 4, 2019
ARES
Device
EU MDD
·
Eu Md Class 2a
·AthenaDiaX GmbH·On the market·2 countries
ARES
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·AthenaDiaX GmbH·1 device
Merck Healthcare KGaA
Authorized representative
🇩🇪 Germany·1 Manufacturer·47 Devices
IgG4 Screen Mediterranean ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
immunoLINE IgG4 MX1
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
immunoLINE IgG4 MX3
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
immunoLINE IgG4 MX2
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG Screen Nutritional 44 IN ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
RF-Absorbens
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG Screen Nutritional 24 ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG Screen Nutritional 40 ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG Screen Select 7 ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG Screen Select 6 ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG Screen Select 5 ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG Screen Select 4 ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG4 Screen Nutritional LDW278 ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
IgG4 Screen Nutritional K44 ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
Tetanus Toxid IgG ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device
Diphtheria Toxid IgG ELISA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·1 device