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# Class 2 for Indirect Immunofluorescence Microscope
- URL: https://www.fdaweb.com/class-2-for-indirect-immunofluorescence-microscope/
- Published: 2017-11-14T12:00:00.000Z
- Updated: 2026-09-14T23:01:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140124

*Federal Register* notice: FDA has classified the automated indirect immunofluorescence microscope and software-assisted system into Class 2 (special controls). The classification is in response to a 2014 de novo classification request from Inova Diagnostics for its NOVA View Automated Fluorescence Microscope. The agency is codifying the classification by adding 21 CFR 866.4750, and it has named the generic type of device automated as “indirect immunofluorescence microscope and software-assisted system.” It is identified as a device that acquires, analyzes, stores, and displays digital images of indirect immunofluorescent slides, and intended to be used as an aid in the determination of antibody status in clinical samples. The device may include a fluorescence microscope with light source, a motorized microscope stage, dedicated instrument controls, a camera, a computer, a sample processor, or other hardware components. The software may include fluorescent signal acquisition and processing software, data storage and transferring mechanisms, or assay specific algorithms to suggest results. A trained operator must confirm results generated with the device. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-14/pdf/2017-24585.pdf?ref=fdaweb.com).