15 results
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27ms
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Sources: EU EUDAMED, US FDA
Biocartis NV
Manufacturer
🇧🇪 Belgium·3 Basic UDI-DIs·3 Devices
BIOCARTIS NV
FDA registration
BIOCARTIS NV·4 products·🇧🇪 Belgium
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™ System
FDA UDI
Biocartis NV·05415219000126·The Idylla™ Console is a computer with a vertic...
Idylla™ MSI Test
FDA UDI
Biocartis NV·15415219000758·The Idylla MSI Test, for use on the Idylla Syst...
Idylla CDx MSI Test
FDA UDI
Biocartis NV·15415219001328·For in vitro diagnostic use. For Prescription U...
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™ 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 INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
FDA Enforcement
Class II
·Ongoing·Biocartis Nv·January 22, 2025
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
FDA Recall
Open, Classified
·Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium·Product code OOI·December 10, 2024