NEW YORK (360Dx) – Quidel said on Tuesday that the US Food and Drug Administration has given 510(k) clearance and a CLIA waiver for its Sofia Influenza A+B fluorescent immunoassay operating on the Sofia 2 analyzer.

The combination is cleared for use in the rapid, differential detection of Influenza types A and B from direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens, and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media from symptomatic patients, Quidel said.

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.