iseki............you would be American by any chance would you? I ask because you seem to think the FDA runs the world in regard to health issues!
Here in Australia it is the TGA. The FDA has no regard here in aussie at all. Europe is the same with their own system. South America again similar such as Brazil etc. South Africa has its own system.
See where I am going with this?
Put bluntly The FDA is not going to be an issue for the NON USA countries in regard to a COVID19 tester.
Ask Brazil with its huge daily death toll and new infections going out of control if they will want an FDA approval before they decide to use it to save their country! For them its not just about health but also more about economy and being able to get people working again.
Most countries have special allowances for any covid19 medical breakthroughs so a commercial BRN Tester will be put to good use VERY quickly!
Especially since it is non invasive, non medicine application just says .....yes/no.
Yak52
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