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Thursday, May 28, 2020 10:24:35 AM
Without the box printed and inside instructions printed and approved via the FDA, no test "kit" can exist. If KB would have said, "Yes, we have test kits", then they could have shut him down for lying.
So "test kits" will not be manufactured and assembled unless DECN gets FDA EUA or approval, simple as that.
The science and testing as of April 13th was all done by Musho and company in South Korea, so shouldn't be alarmed if KB didn't demand a Zoom conference call to be sure Musho wasn't pulling his leg,
![smile](/images/emoticon01.gif)
Keep in mind, that The Bio is the company that has the registered devices with the FDA per other posters' links here on this MB. KB is the US contact rep. The Bio manufactures the devices, Musho and other scientists are the ones who have designed and tested the COVID-19 test strips to work with the existing Precise meter so that a new device would not need to be developed which KB early on in the PRs stated would cut months off the development timeframe.
Also, remember that KB in early PRs about entering the COVID-19 testing arena laid out a plan that would see manufacturing and sales by late summer 2020.
So we are still on a pretty early time frame, though I too would like to see FDA testing and results. As far as FDA review, they mentioned having one person assigned to the product and stated in PRs that they knew of 72 other companies ahead of them having applied for EUA. Who knows how many of the 72 have completed the review process? DECN may be waiting in line.
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