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Biocartis NV Generaal de Wittelaan 11 B3 2800 Mechelen, Belgium http://www.biocartis.com
Contact Ms Renate Degrave +32 15 63 17 29
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Biocartis NV

Biocartis submits 510(k) file with US FDA for Idylla(TM) platform

Submission done in parallel with 510(k) submission of Janssen Idylla(TM) Respiratory (IFV-RSV) Panel Test by Janssen Diagnostics

(PresseBox) (Mechelen, Belgium, )
Biocartis Group NV ('Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the 510(k) submission[1] to the U.S. Food and Drug Administration (FDA) of its rapid, fully automated molecular diagnostics platform Idylla(TM), consisting of the Idylla(TM) Instrument and the Idylla(TM) Console.

The submission was done in parallel with the 510(k) submission by Biocartis' strategic partner Janssen Diagnostics (a Janssen Pharmaceutical Company of Johnson & Johnson) of the Janssen Idylla(TM) Respiratory (IFV-RSV) Panel Test. This test, developed by Janssen Diagnostics on the Idylla(TM) platform, is intended for the detection of various strains of Influenza Virus (IFV) and Respiratory Syncytial
Tvwxt (JGF).

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.