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.

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