> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Spore Test Strip Put Into Class 2
- URL: https://www.fdaweb.com/spore-test-strip-put-into-class-2/
- Published: 2022-02-11T12:00:00.000Z
- Updated: 2026-09-14T17:32:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151142

*Federal Register* notice: FDA is classifying the spore test strip into medical device Class 2 (special controls). The action was taken in response to a Steris de novo classification request for its Verify Spore Test Strip for S40\. It consists of a carrier or strip with a known number of spores of known resistance to a particular liquid chemical sterilant in a liquid chemical sterilant processing system. A “no growth” result from the spore test strip indicates that the liquid chemical sterilization process achieved the conditions necessary to kill the specified minimum number of viable spores. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-03104.pdf?ref=fdaweb.com).