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EliTech Herpes Simplex Virus Assay, Sample-to-Answer Instrument Get FDA Clearance

Oct 31, 2018

NEW YORK (GenomeWeb) – Molecular diagnostics maker EliTech Group has received 510(k) clearance from the US Food and Drug Administration for a sample-to-results diagnostic instrument and an assay to detect and differentiate herpes simplex viruses 1 and 2.

The instrument and assay are now commercially available in the US, the firm said.

The ELITe MGB HSV 1&2 Assay is cleared for use on swab specimens from cutaneous or mucocutaneous lesions in symptomatic patients with cold sores or genital herpes.

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