6:18 PM PHT Rappler.com (2nd UPDATE) The Philippine Food and Drug Administration has approved these RT-PCR, antigen, and antibody rapid test kit brands for commercial use, based on the

Molecular SARS-CoV-2 Diagnostic Tests for COVID-19 that have been granted a De Novo, 510(k) clearance or PMA. BioFire Respiratory Panel 2.1 (RP2.1) - On 

CDC strongly encourages everyone who uses a self-test to report any positive results to their healthcare provider. Healthcare providers can ensure that those who have tested positive for COVID-19 receive the most appropriate medical care, including specific treatments if necessary. In most jurisdictions, healthcare providers who diagnose COVID-19 are required to report those cases to public health. The US Government does not want to construct any barriers that would deter the use of self-tests.  COVID-19 surveillance continues to be based on results from laboratory testing. The primary role of case reporting is to allow public health agencies to take actions to mitigate disease spread. The public health community, including CDC, is confident that situational awareness remains strong without receiving self-test results.

Today, FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, the first direct-to-consumer (non-prescription) multi-analyte 

26 rows · Sep 06, 2022 · Clarity COVID-19 Antigen Rapid Test Cassette; OVIOS COVID-19

Irene Bosch developed a quick, inexpensive COVID-19 test in early 2020. The Harvard-trained scientist already had a factory set up. But she was stymied by an FDA process experts say made no sense

WASHINGTON (AP) — If you were exposed to COVID-19, take three home tests instead of two to make sure you're not infected, according to new 

FDA issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 

At-home COVID-19 tests have a shelf life, but the expiration date on the box may be incorrect. When the U.S. Food & Drug Administration approved the usage of at-home rapid tests, most were given a shelf life of four to six months, says Dr. Jeffrey Jahre, senior vice president of medical and academic affairs at St. Luke’s University Health Network.

The Food and Drug Administration yesterday listed all over-the-counter COVID-19 diagnostic tests authorized for home use, including links to 

E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results, The FDA has identified this as a Class I recall, the most