RE:RE:ApprovalMIR has been at this game for over 20 years, I highly doubt they'd apply if they didn't qualify. The big question is how many units has WebbDX sold, in their April 23 NR they said they will now be marketing the kit. I also found this on their website under FAQ's..Are your tests available for hospitals and nursing homes? Yes. We are scaling up production to increase the number of tests available and are identifying additional distribution partners. The test can be easily and inexpensively mass produced to meet the countrys urgent demand for a point-of-care antibody test that can be used in a variety of settings both in and outside of the lab. Why don't they say how many they have sold, other testing companies mentioned their sales before they got approved.