Which OTC combination Covid and flu tests are FDA approved?

November 18, 2024 8:49 AM

Pretty much what it says on the tin; details below.

I saw an article today from NPR regarding OTC (over the counter) at home test kits for both Covid and the flu.

The article mentioned one specific brand authorised by the FDA, but not the other eight.

https://www.npr.org/sections/shots-health-news/2024/11/18/nx-s1-5147242/covid-flu-home-test

I looked on the FDA website with no success (although I easily found their table of authorised Covid tests). I also contacted NPR.

Perhaps the skilled researches of MeFi can assist? Many thanks!

posted by kyraU2 to Health & Fitness (2 answers total)

Healgen Rapid Check has full approval.

Others are authorized by the FDA, but provisionally.
posted by mark k at 9:20 AM on November 18 [1 favorite]

Here's the entry showing clearance of the assay at FDA's website. Here's the press release with similar details.
posted by Tandem Affinity at 9:50 AM on November 18