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# Bacillus Species IVDs Put Into Class 2
- URL: https://www.fdaweb.com/bacillus-species-ivds-put-into-class-2/
- Published: 2019-04-01T12:00:00.000Z
- Updated: 2026-09-15T01:17:14.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143744

*Federal Register* notice: FDA has issued a final rule to classify *in vitro* diagnostic devices for *Bacillus* species detection into Class 2 (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of device safety and effectiveness. An *in vitro* diagnostic device for *Bacillus* species detection is a prescription device used to detect and differentiate among *Bacillus* species and presumptively identify *B. anthracis* and other related species from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by *Bacillus* species. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-04-01/pdf/2019-06026.pdf?ref=fdaweb.com).