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FDA Coronavirus (COVID-19) Update: Emergency Use Authorization issued for Symbiotica COVID-19 Self-Collected Antibody Test System

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: April 10th, 2021

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA issued a letter to health care personnel and facilities recommending transition from use of decontaminated disposable respirators.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: March 27th, 2021

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

On March 23rd, 2021, the FDA issued an emergency use authorization (EUA) to the Twist Bioscience Corporation for their SARS-CoV-2 NGS Assay.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: March 21th, 2021

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

On March 16th, the FDA posted a new web page on FDA.gov, Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: March 10th, 2021

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) announced Tuesday, March 9th, 2021 that the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19.

COVID-19 Coronavirus

COVID-19 Coronavirus

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Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies.

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test

 

U.S. Food and Drug Administration (FDA)Washington D.C. – The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use.

The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.

Coronavirus.

Coronavirus.

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FDA Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Today, Monday, March 1st, 2021,  the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Coronavirus Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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FDA Issues Emergency Use Authorization for Janssen COVID-19 Vaccine

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Today, February 27th, 2021,  the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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FDA Coronavirus (COVID-19) Update: February 20th, 2021

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

COVID-19 Coronavirus

COVID-19 Coronavirus

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