Panels › Microbiology › Product code PLO · Class 2
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Regulation 866.3970
0510(k)s in 12 months (4 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in PLO
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics, LLC | 2 | 1 |
| Diasorin Molecular, LLC | 1 | 1 |
| QIAGEN GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2024 | K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel QIAGEN GmbH, DE | PLO |
| May 13, 2019 | K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack Diasorin Molecular, LLC | PLO |
| Mar 17, 2016 | K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch Biofire Diagnostics, LLC | PLO |
| Oct 8, 2015 | DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel Biofire Diagnostics, LLC | PLO |
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