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.