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# Certain Devices for Detecting Microbial Pathogens into Class 2
- URL: https://www.fdaweb.com/certain-devices-for-detecting-microbial-pathogens-into-class-2/
- Published: 2017-10-17T12:00:00.000Z
- Updated: 2026-09-14T22:56:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139883

*Federal Register* notice: FDA has classified nucleic acid-based devices for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into Class 2 (special controls). The classification requested was submitted in a 5/2014 *de novo* petition from T2 Biosystems for the T2Candida Panel and T2Dx Instrument. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-16/pdf/2017-22287.pdf?ref=fdaweb.com).