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
K060540 CEPHEID XPERT, GENEXPERT DX SYSTEM 07/25/2006
K181156 Diagenode Panther Fusion GBS Assay 07/27/2018
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


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