NEW YORK (GenomeWeb) – Quidel has received clearance from the US Food and Drug Administration for two assays, the firm announced late yesterday. An assay to detect Group B Strep (GBS) using the firms Solana molecular system received 510(k) clearance from the FDA, while an assay to detect Group A Strep on its Sofia 2 fluorescent immunoassay analyzer received simultaneous 510(k) clearance and CLIA waiver.

To read the full story....

Register for Free.

...and receive Daily News bulletins.

Already have a 360Dx or GenomeWeb account?
Login Now.