aprovalI believe we are dealing with the influance of the U.S. federal government and a President who thinks everything should be made in the U.S.A. and the F>D>A is holding things up because Therma is a Canadian Company , and they are slow in aproval for that reason . The canadian government should be taking more interest in therma and its product . there is such a need for testing with a proven product that I bellieve therma has .The two governments are not taking notice of therma who can provide great numbers of tests that are needed now . IMHO .