> ## 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.

# Assayed Quality Control Material Placed Into Class 2
- URL: https://www.fdaweb.com/assayed-quality-control-material-placed-into-class-2/
- Published: 2017-07-27T12:00:00.000Z
- Updated: 2026-09-14T22:36:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139240

*Federal Register* notice: FDA has classified the assayed quality control material for clinical microbiology assays into Class 2 (special controls). The classification decision is based on a 2015 request from Bio-Rad Laboratories for classification of the Amplichek II device. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-07-27/pdf/2017-15858.pdf?ref=fdaweb.com).