Fluxion Registers Facility with FDA for Manufacture of IsoFlux System | GenomeWeb

NEW YORK (GenomeWeb News) – Fluxion Biosciences said today it has registered its South San Francisco, Calif., facility as a medical device facility with the US Food and Drug Administration.

Registration with the agency is required in order to manufacture in vitro diagnostic instruments and kits. Fluxion said it will use the facility to manufacture and distribute its IsoFlux System for circulating tumor cell analysis, which it plans on launching as a Class I medical device for In Vitro Diagnostic use next month.

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