Uh, in FDA-speak the word "DISTRIBUTE" = USE. Sorry. That's how it "works". PERIOD !
It's known in legal terms as "sold or allowed/released INTO THE STREAM OF COMMERCE", that's what the FDA uses when suing a person/company in civil or criminal court.
IF the FDA grants permission to "distribute the kits", aka lets them "into the stream of commerce" then those kits are "APPROVED" and the re-labeling taking place AS WE SPEAK will clearly notate how/when/where/by whom said kits can be used, which will of course be "medical professionals" NOT home users, etc.