Biofilm detection kit, FDA approval needed? regulatory experts needed

Dear colleagues,

I am currently working for a company on a chemical product that allows detecting biofilm in food processing equipment.

The product is used as follows: after cleaning and sanitation, the product is sprayed on the surface of interest and after a certain period of reaction (>10 min) a development of color indicates that there is biofilm adhered to the surface. If no color is developed that means that the area is clean and free of microbial biofilm. Once the test is performed all residues of the chemical shall and can be easily removed by a good rinse with water, just like any detergent (chemical composition is water soluble). The product is not intended as a cleaner or sanitizer; it is used just as a verification tool.

The company fabricates the product outside the US and they want to commercialize it here and get the required registration or certifications. 

What type of registration or certificate do they need? Do they require a FDA approval, certificate or registration for this type of product? 

Thanks a lot for all your help!

Sincerely

ZAWAPE

I guess my first question is it food safe which by virtue means FDA or other approval. What is the nature of the dye is it easily removed? etc etc