Panels › Clinical Chemistry › Product code OOI · Class 2
Real Time Nucleic Acid Amplification System
Regulation 862.2570
0510(k)s in 12 months (14 all time)
0recalls in 12 months (30 all time)
16recalls that name a 510(k)
Top companies in OOI
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Molecular, Inc. | 1 | 8 |
| Luminex Corporation | 3 | 6 |
| Meridian Bioscience, Inc. | 3 | 2 |
| Roche Molecular Systems, Inc. | 0 | 4 |
| bioMerieux, Inc. | 1 | 1 |
| DiaSorin Molecular LLC | 0 | 2 |
| Roche Diagnostics Operations, Inc. | 0 | 2 |
| Alere Scarborough, Inc. | 1 | 0 |
| Bd Diagnostic | 0 | 1 |
| Becton Dickinson & Co. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2025 | K243922 | Revogene Meridian Bioscience, Inc. | OOI |
| Jan 26, 2023 | K222779 | Revogene Meridian Bioscience, Inc. | OOI |
| Jul 11, 2022 | K220480 | Revogene Meridian Bioscience, Inc. | OOI |
| May 25, 2017 | K170558 | revogene Genepoc, Inc., CA | OOI |
| Jun 30, 2016 | K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) Luminex Corporation | OOI |
| Apr 12, 2016 | K160517 | ARIES System Luminex Corporation | OOI |
| Oct 6, 2015 | K151917 | ARIES System Luminex Corporation | OOI |
| Jul 16, 2015 | K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A Alere Scarborough, Inc. | OOI |
| May 20, 2014 | K140447 | BD VIPER LT SYSTEM Becton, Dickinson and Company | OOI |
| Mar 8, 2013 | K123955 | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT Life Technologies Corporation | OOI |
| Feb 6, 2012 | K113319 | ROTOR-GENE Q MDX QIAGEN GmbH | OOI |
| Oct 29, 2010 | K102314 | 3M INTEGRATED CYCLER (110V) & (220V) Focus Diagnostics, Inc. | OOI |
| Jul 6, 2010 | K093383 | NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG bioMerieux, Inc. | OOI |
| May 28, 2010 | K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 Abbott Molecular, Inc. | OOI |
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