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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2025 | Meridian Bioscience Inc Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay Open, Classified |
NJR | K121044 |
| Jan 21, 2025 | Becton Dickinson & Co. BD PCR Cartridges used with MAX System. Model Number: 437519 Open, Classified |
NJR | K111860 |
| Jan 14, 2025 | Hologic, Inc. Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. Open, Classified |
NJR | K181156 |
| Apr 6, 2022 | Hologic, Inc Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. Open, Classified |
NJR | K181156 |
| Aug 15, 2019 | Luminex Corporation ARIES GBS Assay , REF 50-10021, UDI # 00840487100165 Open, Classified |
NJR | K162772 |
| Dec 29, 2015 | Biomerieux Inc Granada Biphasic Broth
The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. Terminated |
NJR | None listed |
| Jul 3, 2013 | Becton Dickinson & Co. BD MAX Instrument, catalog #441916
Product Usage:
The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of targ Terminated |
NJR | K111860 |
| Mar 22, 2013 | Becton Dickinson & Co. BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Gro Terminated |
NJR | K111860 |
| Jan 22, 2013 | Becton Dickinson & Co. Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument. Terminated |
NJR | K111860 |
| May 31, 2011 | Cepheid Xpert Infinity Software, V 4.1a.
Cepheid, Sunnyvale, CA 94089
system software for GeneXpert Infinity 48 Terminated |
NJR | K103766 |
| Jan 12, 2008 | Cepheid Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089 Terminated |
NJR | K060540 |
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