Close Menu

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.

To read the full story....

...and receive Daily News bulletins.

Already have a 360Dx or GenomeWeb account?
Login Now.

Don't have a 360Dx or GenomeWeb account?
Register for Free.

Apr
29
Sponsored by
Co-Diagnostics

Join Dr. Heather Fehling, Chief Scientific Officer at Clinical Reference Labs (CRL), as she provides some insights regarding the future applications of PCR testing.

May
13
Sponsored by
LGC SeraCare Life Sciences

As we pass the one-year anniversary of both the COVID-19 pandemic and the first Emergency Use Authorized SARS-CoV-2 PCR detection assays, there remains significant opportunity for clinical laboratories to advance testing and support improved patient management.

May
18
Sponsored by
Bio-Rad

This webinar will present the details of a COVID-19 saliva screening program that has been implemented at more than 90 different colleges, universities, private schools, and nursing homes across New York state.