www.fdanews.com/articles/189031-fda-clears-elitechgroups-herpes-assays
FDA Clears ELITechGroup’s Herpes Assays
November 2, 2018
ELITechGroup’s real-time PCR assays for detecting herpes simplex viruses 1 & 2 has been given 510(k) clearance by the FDA.
The assays, which are used with the company’s InGenius sample-to-result device, can detect and differentiate between herpes simplex viruses 1 & 2.
The assays analyze nucleic acid obtained from the patient’s lesions on the skin, genital, lips or mouth.