Quantum Materials Corp. (fka QTMM)

[TedJ]

Couple of points.
The March PR was referring to test kits that were probably manufactured in Hong Kong and German for the Chinese and sold to MIG USA.

Those tests may have had a different label and may have been submitted for EUA under the earlier FDA Umbrella EUA.

I'm not sure I have figured out what the FDA is doing, but it appears that the FDA has revoked the earlier Umbrella EUA on July 21 2020.

https://www.fda.gov/media/140351/download

Based on information and experience since issuance of the umbrella EUA, FDA has determined that circumstances support revocation of the umbrella EUA so that FDA may issue individual EUAs. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella UA. Accordingly, FDA has decided to revoke this EUA. Instead, FDA will issue individual
EUAs for SARS-CoV-2 Antibody Tests that meet the requisite EUA statutory criteria.

It now appears that antibody tests need to be individually authorized for EUA so the authorized list got a lot shorter.

The VITAK-19 test may have been authorized earlier but now be in for individual authorization under the new rules.

At this point I'm guessing.