Monday, February 6, 2023
Home COVID-19 Coronavirus (COVID-19) Update: June 1, 2021

Coronavirus (COVID-19) Update: June 1, 2021

0
178
For Fast Launch:

The U.S. Meals and Drug Administration at this time introduced the next actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA issued a security communication to warn the general public to cease utilizing the Lepu Medical Expertise SARS-CoV-2 Antigen Speedy Check Package and the Leccurate SARS-CoV-2 Antibody Speedy Check Package (Colloidal Gold Immunochromatography) as a result of the FDA has critical considerations in regards to the efficiency of the assessments and believes there may be possible a excessive threat of false outcomes when utilizing these assessments. Neither check has been licensed, cleared, or permitted by the FDA. The FDA has recognized this challenge as a category I recall, which is probably the most critical kind of recall. The FDA is conscious that these unauthorized assessments had been distributed to pharmacies to be bought for at-home testing by customers, in addition to supplied on the market on to customers.
  • Testing updates:
    • As of at this time, 380 assessments and pattern assortment units are licensed by the FDA below emergency use authorizations (EUAs). These embody 275 molecular assessments and pattern assortment units, 80 antibody and different immune response assessments and 25 antigen assessments. There are 52 molecular authorizations and one antibody authorization that can be utilized with home-collected samples. There may be one molecular prescription at-home check, two antigen prescription at-home assessments, 4 antigen over-the-counter (OTC) at-home assessments and two molecular OTC at-home assessments.
    • The FDA has licensed 9 antigen assessments and three molecular assessments for serial screening packages. The FDA has additionally licensed 516 revisions to EUA authorizations.

Associated Data

###

Boilerplate

The FDA, an company throughout the U.S. Division of Well being and Human Providers, protects the general public well being by assuring the security, effectiveness, and safety of human and veterinary medicine, vaccines and different organic merchandise for human use, and medical units. The company is also answerable for the security and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.


LEAVE A REPLY

Please enter your comment!
Please enter your name here