[CPA]

Ventana provides test kits. These kits have been FDA approved and contain the antibodies needed to identify the specific items listed in your post, however the kits do not contain some common laboratory items (dewaxing agent, ethanol, sterile water, formalin, some stains, etc.). These items are made by various companies, and are used interchangeably with various tests. Often, these items are not individually FDA approved.

During the FDA approval process, Ventana obviously did not submit every possible combination of stains/reagents/ovens/microscopes, etc. usable with their products. It appears that this is just legalese to protect the company and the lab. The important part is the last sentence - controls were run showed appropriate staining.