FDA Product Code NJR: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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.
Leading manufacturers include Cepheid, Becton, Dickinson & CO and Neumodx Molecular, Inc..
18
Total
18
Cleared
171d
Avg days
2002
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test Devices (Product Code NJR)
18 devices
Cleared
Sep 27, 2023
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
Cepheid
Microbiology
391d
Cleared
May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
Cepheid
Microbiology
535d
Cleared
Nov 07, 2018
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
Diasorin Molecular, LLC
Microbiology
58d
Cleared
Jul 27, 2018
Panther Fusion GBS Assay
Diagenode
Microbiology
87d
Cleared
Jun 26, 2018
NeuMoDx GBS Assay
Neumodx Molecular, Inc.
Microbiology
203d
Cleared
Feb 16, 2012
BD MAX GBS ASSAY, BD MAX INSTRUMENT
Becton, Dickinson & CO
Microbiology
231d
About Product Code NJR - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code NJR since 2002, with 18 receiving FDA clearance (average review time: 171 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.