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Quidel obtains two FDA clearances for diagnostic tests

Quidel has obtained the US Food and Drug Administration (FDA) approval for two infectious disease tests that run on Life Technologies' QuantStudioDx instrument.

Life Technologies’ QuantStudioDx instrument offers the advanced capabilities in flexible sample batching needed by higher-volume hospital and reference laboratories.

The two 510(k) clearances add to the infectious disease menu available on the QuantStudio Dx instrument with assays for the diagnosis of some of the more common respiratory tract infections that often share similar influenza-like symptoms (ILI) and that can be difficult to distinguish, based on clinical signs and symptoms alone.

The Quidel Molecular Influenza A+B assay reports the presence or absence of influenza A and/or B virus; it does not differentiate influenza A subtypes.

While the Quidel Molecular RSV + hMPV assay detects the presence of respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV).

Life Technologies president of genetic analysis and medical sciences Ronnie Andrews noted the partnership with Quidel constitutes a key component of company’s strategy to expand its presence in the diagnostics space.

"We will continue to pursue the opportunity to partner to add content to our FDA Cleared systems in key disease areas," Andrews added.

Both the assays were previously 510(k)-cleared by the FDA for use with Life Technologies’ Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and Cepheid’s SmartCycler II.