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Quidel gains FDA approval for strep test

Quidel Corp. (Nasdaq: QDEL), a San Diego-based provider of rapid diagnostic testing solutions, reports it has received clearance from the Food and Drug Administration (FDA) to market its Lyra Direct Strep Assay.

This new molecular test detects and differentiates between pyogenic Group A and pyogenic C or G Streptococcal throat infections.

The assay kit includes an extraction-free, three-step sample preparation process that does not require automated extraction. This fast and easy direct-to-amplification procedure allows the assay to generate a result in just over an hour.

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Quidel Corp.

Company Website

10165 McKellar Ct.
San Diego, CA 92121

Quidel Corp. Executive(s):

Douglas Bryant

  • Chief Executive Officer, President

Randall Steward

  • Chief Financial Officer

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NAICS - 325413 - In-Vitro Diagnostic Substance Manufacturing