Maybe explains why we have not heard anything yet. Hopefully, they're smart enough to ship batches as they re-label, and not wait until all 100,000 kits are re-labeled before they ship any.
Bureaucracy at its finest...
"In fact, even today, [Pitkin County medical officer Kim] Levin learned that the United States Food and Drug Administration ordered Aytu to relabel its new test. On Monday, the company announced that, having gotten FDA approval, it would begin distributing 100,000 tests nationwide.
“I got an email today saying they have to relabel all their tests, so now they might not be out until later next week,” she said. “This is the flow. Yesterday, we had all this promise that it might happen in a couple of days, and today, it’s totally different. They’re getting FDA approval right now.”"