Product code PLO— Microbiology
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
- Classification name
- Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- Device class
- Class 2
- Regulation
- 21 CFR 866.3970
- Advisory panel
- Microbiology
- Total cleared
- 4
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PLO
FDA has cleared devices under product code PLO between 2015 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2019
- 2016
- 2015
Top applicants under product code PLO
Adverse events under product code PLO
product code PLO- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code PLO
Data sourced from openFDA. This site is unofficial and independent of the FDA.