I may be wrong, but rereading the post this is a r
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Posted On: 05/04/2021 4:11:52 PM
I may be wrong, but rereading the post this is a reply to, it seems Innova and QMC HealthID are pursuing both a EUA for the antigen test and the QMCH platform and reader device, under rule 510 FDA approval for normal medical devices use.
The CITI test could be encompassing the larger goal of getting all components approved at one time, so as not to have to keep going back again and again. That possibly explains the longer approval process.
The CITI test could be encompassing the larger goal of getting all components approved at one time, so as not to have to keep going back again and again. That possibly explains the longer approval process.
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