Atlas FDA

NJR

18 FDA 510(k) clearances · Product code

133 daysmedian time to decision
485 days90th percentile
18clearances measured

FDA profile

Official device name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device class
Class I (low risk)
Regulation
21 CFR 866.3740
Medical specialty
Microbiology
FDA definition
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.
Adverse events (MAUDE)
2026: 49
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems (K222638)Cepheid2023-09-27
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System (K203429)Cepheid2022-05-09
Simplexa GBS Direct, Simplexa GBS Positive Control Pack (K182467)Diasorin Molecular, LLC2018-11-07
Panther Fusion GBS Assay (K181156)Diagenode2018-07-27
NeuMoDx GBS Assay (K173725)Neumodx Molecular, Inc.2018-06-26
Solana GBS Assay (K173250)Quidel Corporation2017-12-21
GenePOC GBS LB (K170557)Genepoc, Inc.2017-05-25
ARIES GBS Assay (K162772)Luminex Corporation2016-12-23
Portrait GBS Assay (K143312)Great Basin Corporation2015-04-21
AMPLIVUE GBS ASSAY (K133503)Quidel Corporation2013-12-20
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) (K121539)Cepheid2012-11-02
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM (K121044)Meridian Bioscience, Inc.2012-05-01
BD MAX GBS ASSAY, BD MAX INSTRUMENT (K111860)Becton, Dickinson & CO2012-02-16
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT (K112125)Meridian Bioscience, Inc.2011-12-05
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB (K090191)Handylab, Inc.2010-05-27
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B (K062948)Cepheid2006-12-08
XPERT, GENEXPERT DX SYSTEM (K060540)Cepheid2006-07-25
IDI-STREP B ASSAY (K022504)Infectio Diagnostic, Inc.2002-11-18

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Every clearance here is in the API, with alerts when new ones post.