FDA 510(k) Applications for Medical Device Product Code: NJR (Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test)

FDA 510(k) Applications for Medical Device Product Code "NJR"
(Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K111860	BECTON DICKINSON & CO.	BD MAX GBS ASSAY, BD MAX INSTRUMENT	02/16/2012
K062948	CEPHEID	SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B	12/08/2006
K121539	CEPHEID	XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)	11/02/2012
K203429	Cepheid	Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System	05/09/2022
K060540	CEPHEID	XPERT, GENEXPERT DX SYSTEM	07/25/2006
K222638	Cepheid	Xpert« Xpress GBS, GeneXpert« Dx System, GeneXpert« Infinity Systems	09/27/2023
K181156	Diagenode	Panther Fusion GBS Assay	07/27/2018
K182467	DiaSorin Molecular LLC	Simplexa GBS Direct, Simplexa GBS Positive Control Pack	11/07/2018
K170557	GenePOC Inc.	GenePOC GBS LB	05/25/2017
K143312	GREAT BASIN CORPORATION	Portrait GBS Assay	04/21/2015
K090191	HANDYLAB, INC	HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB	05/27/2010
K022504	INFECTIO DIAGNOSTIC, INC.	IDI-STREP B ASSAY	11/18/2002
K162772	LUMINEX CORPORATION	ARIES GBS Assay	12/23/2016
K112125	MERIDIAN BIOSCIENCE, INC.	ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT	12/05/2011
K121044	MERIDIAN BIOSCIENCE, INC.	ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM	05/01/2012
K173725	NeuMoDx Molecular, Inc.	NeuMoDx GBS Assay	06/26/2018
K133503	QUIDEL CORPORATION	AMPLIVUE GBS ASSAY	12/20/2013
K173250	Quidel Corporation	Solana GBS Assay	12/21/2017