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# FDA Clears EliTechGroup Herpes Test
- URL: https://www.fdaweb.com/fda-clears-elitechgroup-herpes-test/
- Published: 2018-10-31T12:00:00.000Z
- Updated: 2026-09-15T00:41:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142714

FDA has cleared an EliTechGroup 510(k) for its HSV 1&2 ELITe MGB Real-Time PCR assay with the ELITe InGenius sample-to-result instrument. The new molecular test is intended to detect and differentiate herpes simplex viruses 1 and 2 nucleic acid isolated from swab specimens from cutaneous (skin) or mucocutaneous (eg., genital, lips, mouth) lesions on symptomatic patients. It is designed for use on the ELITe InGenius instrument, an automated, sample-to-result benchtop molecular diagnostic instrument performing all steps from sample extraction to results analysis that can perform up to 12 tests per run with hands-on time of less than two minutes per sample, according to the company.