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www.fdanews.com/articles/179479-quidels-solanar-molecular-assay-achieves-fda-clearance

Quidel’s Solana(R) Molecular Assay Achieves FDA Clearance

November 30, 2016

Quidel has received clearance from the FDA to market its Solana herpes assay for the detection and identification of different types of herpes and varicella from lesion samples obtained from patients showing symptoms.

Solana can process up to 12 patient samples in each run.

The assay is not intended for use with cerebrospinal fluid or to aid in the diagnosis of herpes or varicella infections of the central nervous system nor in prenatal screening. — Cynthia Jessup

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