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.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

A former Synthetic Genomics attorney alleges that the firm discriminated against her and other female employees, according to the San Diego Union-Tribune.

Due to privacy and lab certification questions, the planned giveaway of Orig3n testing kits at a Baltimore Ravens game was suspended.

Alnylam reports positive results from its phase 3 clinical trial of an RNAi-based drug, according to Stat News.

In Cell this week: adult mesenchymal cell populations in mouse lung, genetic diversity in HPV16 and cancer risk protection, and more.