illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10

K151046 is the FDA 510(k) clearance record for illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10, a class II device, cleared for Meridian Bioscience, Inc. on 2015-07-17 under FDA product code PGI (Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples). FDA's definition for product code PGI reads: "For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid". FDA records list 38 510(k) clearances for Meridian Bioscience, Inc., from 2003-01-03 to 2025-03-20. As of 2026-09-10, FDA records show no recalls naming K151046.