PLO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3970
- Medical specialty
- Microbiology
- FDA definition
- A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings.
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| Record | Firm | Date |
|---|---|---|
| QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256) | QIAGEN GmbH | 2024-10-29 |
| Simplexa VZV Direct, Simplexa VZV Positive Control Pack (K190219) | Diasorin Molecular, LLC | 2019-05-13 |
| FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch (K160462) | Biofire Diagnostics, LLC | 2016-03-17 |
| FilmArray Meningitis/Encephalitis(ME) Panel (DEN150013) | Biofire Diagnostics, LLC | 2015-10-08 |
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Every clearance here is in the API, with alerts when new ones post.