Dr. Moro,

I do not remember specifically where it was mentioned but at one time some of the potential licensees thought that we may or MAY NOT require an FDA submision and or a 510k approval.

Do we definately require an approval of some sort to use Recaf in the US? and if so Why? In Mexico? In Canada.

Is there a way to label Recaf in such a way that no approval is required such that we can either sell the product as "a potential indicator of cancer" verses labeled as "a cancer diagnostic tool" or only sell the results in lieu of selling the actual test apparatus...

The drawing of blood or extraction of saliva is an everyday occurance. Recaf does not require one to be exposed to any physical harm during the test.

What one does with the results is up to them.