FDA 510(k) Applications for Medical Device Product Code: PGI ()

FDA 510(k) Applications for Medical Device Product Code "PGI"

FDA 510(k) Number	Applicant	Device Name	Decision Date
DEN140004	DIAGNOSTIC HYBRIDS, INC.	QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY	05/13/2014
K173798	DiaSorin Molecular LLC	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	03/14/2018
K192376	DiaSorin Molecular LLC	Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack	11/26/2019
K180559	ELITechGroup	HSV 1 & 2 ELITe MGB Kit; ELITe InGenius	10/29/2018
K151906	LUMINEX CORPORATION	ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)	10/06/2015
K151046	MERIDIAN BIOSCIENCE, INC.	illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10	07/17/2015
K162451	QUIDEL CORPORATION	Solana HSV 1+2/VZV Assay	11/28/2016