59 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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OT 76x26x1 Float ubk oMR V=50 IDL
Device
EU IVDR
·
Eu Ivd Class A
·Paul Marienfeld GmbH & Co. KG·On the market·32 countries
OT 76x26x1 Float ubk 2xMR20 V=50 IDL
Device
EU IVDR
·
Eu Ivd Class A
·Paul Marienfeld GmbH & Co. KG·On the market·32 countries
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
ADL Anti Dekubitus Lagerungssyteme GmbH
Manufacturer
🇩🇪 Germany
IBL INTERNATIONAL GMBH
FDA registration
IBL INTERNATIONAL GMBH·12 products·🇩🇪 Germany
dsDNA-Ab RIA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
17beta-Estradiol Saliva Luminescence Immunoassay
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
17beta-Estradiol Saliva Luminescence Immunoassay
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Acetylcholine Receptor Autoantibodies (ARAb) RRA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Progesterone Saliva ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
DHEA ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
25-OH-Vitamin D ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Acetylcholine Receptor Autoantibodies (ARAb) RRA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Acetylcholine Receptor Autoantibodies (ARAb) RRA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
MuSK-Ab ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
17beta-Estradiol Saliva ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Serotonin Urine ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Melatonin-Sulfate Urine ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
Estriol high sensitive Saliva ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries
17-OH-Progesterone ELISA
Device
EU IVDR
·
Eu Ivd Class B
·IBL International GmbH·On the market·32 countries