List of Tests Approved by FDA

I have just spent time searching the FDA website and feel like a dunce. Nevertheless, I am unable to find a list of FDA-approved rt-PCR and antigen tests. Does anyone have a link where this information is displayed?

More info than you could possibly want

https://www.fda.gov/medical-devices...as-molecular-diagnostic-tests-sars-cov-2

https://www.fda.gov/medical-devices...euas-antigen-diagnostic-tests-sars-cov-2

https://www.fda.gov/medical-devices...daptive-immune-response-tests-sars-cov-2

All have EUA approval

Thanks, boucharda. I was on some of those pages but obviously didn't scroll down far enough. So apparently there aren't really any FDA approved, just EUA approval?

Linda, I believe that all of the approved tests have only been approved under the Emergency Use Authorization protocol. Not sure exactly what's different about that, other than perhaps avoiding the lengthy trials that are normally required. Purely conjecture on my part.

That is the difference

Physicians only preform approved tests. We got our test Friday afternoon and got results back Sunday morning. We put our EHAS application in after church at 11:00 and got approval by 11:20. They want us to come. Wheels up on Wednesday...Cheers.

Do you guys think that there is a better chance of being approved taking the 48 hour antigen test or the 120 hour rt-PCR test? Has there been a trend?

We got the PCR test and it took about 36 hours for results, but my doc said they give him a timeline of 24 to 48 hours. We would've gotten the antigen Monday morning as a back-up if we didn't hear back. I'm glad we did it that way for peace of mind. And like I said earlier, once we submitted to EHAS we had our acceptance in 20 minutes. So either should work. I was just nervous about filling out the application, but it was no big deal. Godspeed.

I have been told not hard to fill out , but when I look at the form I can only see the first section ,is there a way to see the whole form so that I know what outher info I need ?

You can fill out the form with a fake date like your going this week and just don't submit it.

Doesn't make any difference. You provide the info they ask for, you should be approved regardless of whether it is pcr or antigen.

Yup...did that a few times...fake everything just as a rehearsal...

I'm computer numbskull and I had no problem. Just get the results on PDF file, download it to your computer and then to the form. It's very simple. The thought is worse than the reality.

And now that I have needed to start paying attention to this for my June trip, I realize that the day day on which 120 hours hits is . . . Memorial Day. I haven't started calling around to see who might be open on the holiday, but I suspect I'm going to lose 24 of the 120 hours. Nerve-wracking, coming from the West Coast. Will probably also get lined up for the antigen test as a backup.

We took our test thru CVS late Monday afternoon and had results back early morning Wednesday. Submitted the EHAS forms and got the conditional approval early Wednesday morning. Doesn't seem to be much of a delay in getting results back and St Maarten responded back very quickly.

Yes, I would doubt anyone is going to be open Memorial Day. Our 120 hour mark is on a Sunday, so I kind of am assuming I won't be able to find anyone to do the test on a Sunday. But we have more time to play with, versus you. Best wishes!

Thanks, Carol.