BioFire Files 510(k) Submission to FDA for Blood Culture Panel | GenomeWeb

NEW YORK (GenomeWeb News) – BioFire Diagnostics today announced the 510(k) submission of its FilmArray Blood Culture Identification, or BCID, Panel to the US Food and Drug Administration.

The submission follows the successful completion of clinical trials for the panel, which provides automatic results for the most common infectious causes of sepsis. BioFire said that pending clearance from FDA, it anticipates launching the panel in the summer.

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.

In Science this week: ancient Ethiopian genome indicates greater Eurasian backflow into Africa, sequencing to diagnose cutaneous T cell lymphoma, and more.

The US House of Representatives science committee has passed a bill to require NSF to ensure it only funds projects that are in the national interest.

DuPont teams with genome editing firm Caribou Biosciences for agricultural applications of the technology.

A blogger reviews her experience learning about her gut microbiome by shipping a sample to uBiome.