Biocartis NV

Address:Generaal De Wittelaan 11 B,Mechelen Antwerpen,BE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Real Time Nucleic Acid Amplification System (OOI) (2) Respiratory Virus Panel Nucleic Acid Assay System (OCC) (1)

Premarket Exempt

No Yes

Clear

Idylla™ System - 05415219000119 Catalog Number : P0010

Device Description : Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.

Device Class : 2

Duns Number: 400686169

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Idylla™ System - 05415219000126 Catalog Number : P1010

Device Description : The Idylla™ Console is a computer with a vertically oriented touch-screen and a The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch-screen that communicates with the Idylla™ Instruments. Idylla™ Console and up to eight Idylla™ Instruments constitute the Idylla™ System.

Device Class : 2

Duns Number: 400686169

Premarket Exempt : Yes

Product Code : OOI

Prescription Use : Yes

Device Count : 1

Idylla™ Respiratory (IFV-RSV) Panel - 15415219000635 Catalog Number : A1030/6

Device Class :

Duns Number: 400686169

Premarket Exempt : No

Product Code : OCC

Prescription Use : Yes

Device Count : 6

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