Long authorization process is part of nationwide failure to make and distribute enough of the tests, public-health experts say
As rising Covid-19 infections stoked demand for tests across the U.S. in December, California-based LumiQuick Diagnostics Inc. shipped 100,000 rapid tests to a hospital customer—in Germany.
LumiQuick didn’t receive authorization from the Food and Drug Administration to sell Covid-19 tests domestically after waiting several months for a decision.