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Unapproved COVID-19 tests are especially risky because “a lay person [may not have] the ability to collect their specimen, run the test and interpret the test result accurately,” the agency said. Read More
The agency noted that the products are subject to detention and refusal of admission if they are offered for importation into the United States. Read More
The three targeted genetic areas used in the test are unique to the SARS-CoV-2 virus, which reduces the detection of other coronaviruses, the company said. Read More
Qiagen’s QIAreach SARS-CoV-2 Antigen Test can provide results in two to 15 minutes by analyzing more than 30 samples per hour for the antigen of the virus that causes COVID-19. Read More
There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing, but no deaths, the FDA said. Read More
As the Delta variant becomes more widespread, “it's important for those in the healthcare and public sectors to wear quality, tested masks,” a company spokesperson said. Read More