kw and crew have had 2 months to work up a distribution plan, HOPEFULLY. we still have to be able to manufacture the kits to stay up with the demand also.
too much work for the 3 amigos. they better a partner in this already.
if fda approves the use of pmcb licensed covid-19 test kit and since this test kit is suppose to be the best out there...
Yet again again again and again, IF or WHENEVER a EUA is granted the HaiKang RT-PCR test kit is no better or worse than the other RT-PCR test kits which have already flooded the market.
the application is still active with fda... and maybe they are taking a good look at it....
"The application" is to register the device (test kit) intended to be produced and distributed for US use. Unless the device is dangerous to use, the application, and acceptance by the FDA is straight forward. There is no need to take a "good look".
And what does your link repetitively posted mean? Note the small print:
Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.
In another words it has nothing to do with the application and approval for an EUA itself.