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In December, the FDA authorized the use of a rapid testing kit developed by Brisbane, Australia-based Ellume Health. The test is available for purchase without a prescription for about $30 and can give results in about 20 minutes. [62] [63] The FDA approved the test for people with and without COVID symptoms. [63]
QuidelOrtho Corporation is an American manufacturer of diagnostic healthcare products that are sold worldwide. [3]On May 8, 2020 the U.S. Food and Drug Administration (FDA) issued to Quidel the first emergency use authorization (EUA) for a COVID-19 rapid antigen test, a new category of tests for use in the ongoing pandemic.
The FDA gave an EUA for the US' first antibody test on the 2nd. [63] [64] On 5 April, the U.S. subsidiary of China's BGI Group sent a proposal to the state of California offering to build in California, at cost ($10 million), the world's largest COVID-19 testing site, in two weeks, and train Americans to operate it. California's consultants ...
Visby Medical, a startup in Silicon Valley, last week became the first company to receive an Emergency Use Authorization from the Food and Drug Administration for a portable PCR coronavirus test ...
In an effort to ease the diagnostic logjam the United States is facing with the coronavirus surging in various parts of the country, the Food and Drug Administration on Saturday granted an ...
The first COVID-19 diagnostic test to be authorized for pooled samples, it can allow for testing on up to four individual swab specimens at a time, the FDA said. ... The U.S. Federal Drug ...
The California Department of Public Health (CDPH) is the state department responsible for public health in California. It is a subdivision of the California Health and Human Services Agency . It enforces some of the laws in the California Health and Safety Codes , notably the licensing of some types of healthcare facilities.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...