20 results · 69ms · Sources: EU EUDAMED, US FDA

Biocartis NV

Manufacturer
🇧🇪 Belgium·3 Basic UDI-DIs·3 Devices

SeptiCyte RAPID

FDA registration
BIOCARTIS NV·1 product·🇧🇪 Belgium

Idylla™ System (Idylla™ Console and Idylla™ Instrument)

FDA registration
BIOCARTIS NV·1 product·🇧🇪 Belgium

Idylla MSI Test

FDA registration
BIOCARTIS NV·1 product·🇧🇪 Belgium

Idylla™ System

FDA UDI
Biocartis NV·05415219000126·The Idylla™ Console is a computer with a vertic...

Idylla™ Respiratory (IFV-RSV) Panel

FDA UDI
Biocartis NV·15415219000635·

Idylla™ System

FDA UDI
Biocartis NV·05415219000119·Up to eight Idylla™ Instruments and the Idylla™...

Idylla™ MSI Test

FDA UDI
Biocartis NV·15415219000758·The Idylla MSI Test, for use on the Idylla Syst...

Idylla™ Console Software Plus (CSW+)

Device
EU IVDR · Eu Ivd Class A ·Biocartis NV·On the market

Idylla™ Console

Device
EU IVDR · Eu Ivd Class A ·Biocartis NV·On the market

Idylla™ Instrument

Device
EU IVDR · Eu Ivd Class A ·Biocartis NV·On the market

Idylla MSI Test

FDA 510(k)
FDA Class 2 ·Immunology

Idylla™ Console Software Plus (CSW+)

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Biocartis NV·1 device

Idylla™ Console

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Biocartis NV·1 device

Idylla™ Instrument

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Biocartis NV·1 device

Idylla™ MSI FFPE Reference Set

FDA UDI
SensID GmbH·04260712780003·Idylla™ MSI FFPE Reference Set is intended as c...

SensID Idylla™ MSI FFPE Reference Set

FDA UDI
SensID GmbH·04260712780034·Idylla™ MSI FFPE Reference Set is intended as c...

SensID Idylla™ MSI FFPE Reference Set

FDA UDI
SensID GmbH·04260712780058·Idylla™ MSI FFPE Reference Set is intended as c...

SensID Idylla™ MSI FFPE Reference Set

FDA UDI
SensID GmbH·04260712780041·Idylla™ MSI FFPE Reference Set is intended as c...

Idylla™ MSI FFPE Reference Set

FDA UDI
SensID GmbH·04260712780065·Idylla™ MSI FFPE Reference Set is intended as c...