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- Chinese FDA Grants Vela Diagnostics Class I Medica...
Chinese FDA Grants Vela Diagnostics Class I Medical Device for Automated Multi-Purpose Sample Prep Instrument
By Vela Diagnostics
2016-09-20
Singapore (September 20, 2016) – Vela Diagnostics announced today that the Chinese FDA (CFDA) has granted the “Class I Medical Device” status for the Sentosa® SX101 instrument for clinical use.
Michael Tillmann, Vela Diagnostics’ CEO commented: “With the CFDA approval of the first of many instruments in our workflow, we are looking forward to expanding the access for automated clinical molecular diagnostics to one of the largest populations in the world.”
The Sentosa® SX101 is a multi-purpose liquid handling platform with open channel capabilities that automates liquid handling steps in clinical sample extraction. The instrument plays a key role in the Vela Diagnostics Sentosa® PCR and NGS workflow by providing walk away automation for laborious sample preparation.