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# Class 2 for Microbial Pathogen Detectors In Cerebrospinal Fluid
- URL: https://www.fdaweb.com/class-2-for-microbial-pathogen-detectors-in-cerebrospinal-fluid/
- Published: 2017-10-20T12:00:00.000Z
- Updated: 2026-09-14T22:57:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139925

*Federal Register* notice: FDA has classified devices that detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class 2 (special controls). This action is in response to a 4/2015 BioFire Diagnostics request for *de novo* classification of its FilmArray Meningitis/Encephalitis Panel. The agency has named the generic type of device as “a device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid and it is intended to aid in the diagnosis of meningitis or encephalitis when used in conjunction with clinical signs and symptoms and other clinical and laboratory finding.” To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-20/pdf/2017-22769.pdf?ref=fdaweb.com).