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# Cervical Intraepithelial Neoplasia Tests Put Into Class 2
- URL: https://www.fdaweb.com/cervical-intraepithelial-neoplasia-tests-put-into-class-2/
- Published: 2018-01-04T12:00:00.000Z
- Updated: 2026-09-14T23:10:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140422

*Federal Register* notice: FDA has classified the cervical intraepithelial neoplasia (CIN) test system into Class 2 (special controls). The action responds to a 5/2016 *de novo* classification request from Ventana Medical Systems for its CINtec Histology device. The device is used to detect a biomarker associated with CIN in human tissues. It is indicated as an adjunct test and not to be used as a stand-alone device. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-01-03/pdf/2017-28342.pdf?ref=fdaweb.com).