Panels › Microbiology › Product code NJR · Class 1
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Regulation 866.3740
0510(k)s in 12 months (18 all time)
1recalls in 12 months (11 all time)
10recalls that name a 510(k)
Top companies in NJR
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 5 | 2 |
| Becton, Dickinson & CO | 1 | 4 |
| Meridian Bioscience, Inc. | 2 | 1 |
| Hologic, Inc | 0 | 2 |
| Luminex Corporation | 1 | 1 |
| Quidel Corporation | 2 | 0 |
| Biomerieux Inc | 0 | 1 |
| Diagenode | 1 | 0 |
| Diasorin Molecular, LLC | 1 | 0 |
| Genepoc, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 27, 2023 | K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems Cepheid | NJR |
| May 9, 2022 | K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System Cepheid | NJR |
| Nov 7, 2018 | K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack Diasorin Molecular, LLC | NJR |
| Jul 27, 2018 | K181156 | Panther Fusion GBS Assay Diagenode, BE | NJR |
| Jun 26, 2018 | K173725 | NeuMoDx GBS Assay Neumodx Molecular, Inc. | NJR |
| Dec 21, 2017 | K173250 | Solana GBS Assay Quidel Corporation | NJR |
| May 25, 2017 | K170557 | GenePOC GBS LB Genepoc, Inc., CA | NJR |
| Dec 23, 2016 | K162772 | ARIES GBS Assay Luminex Corporation | NJR |
| Apr 21, 2015 | K143312 | Portrait GBS Assay Great Basin Corporation | NJR |
| Dec 20, 2013 | K133503 | AMPLIVUE GBS ASSAY Quidel Corporation | NJR |
| Nov 2, 2012 | K121539 | XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) Cepheid | NJR |
| May 1, 2012 | K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM Meridian Bioscience, Inc. | NJR |
| Feb 16, 2012 | K111860 | BD MAX GBS ASSAY, BD MAX INSTRUMENT Becton, Dickinson & CO | NJR |
| Dec 5, 2011 | K112125 | ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT Meridian Bioscience, Inc. | NJR |
| May 27, 2010 | K090191 | HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB Handylab, Inc. | NJR |
| Dec 8, 2006 | K062948 | SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B Cepheid | NJR |
| Jul 25, 2006 | K060540 | XPERT, GENEXPERT DX SYSTEM Cepheid | NJR |
| Nov 18, 2002 | K022504 | IDI-STREP B ASSAY Infectio Diagnostic, Inc. | NJR |
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