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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | DiaSorin Molecular LLC MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patie Terminated |
PLO | K190219 |
| Sep 10, 2018 | BioFire Diagnostics, LLC -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD
-Fitment Label (P/N RF Terminated |
PLO | None listed |
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