Cue Health Fda Authorization
Listing Websites about Cue Health Fda Authorization
Cue Health Evaluating Warning Letter Received from Food and …
(6 days ago) WebCue received De Novo authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 test, which became the first home use respiratory test to receive this …
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FDA Authorizes Cue Health’s COVID-19 Test for At-Home …
(Just Now) WebWithout a Prescription. San Diego, CA (March 5, 2021) - – Cue Health Inc. (Cue) announced the healthcare technology company has received Emergency Use …
https://cuehealth.com/about/press/fda-authorizes-cue-health's-covid-19-test-for-at-home-and-over-the
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Cue Health Applies with FDA for Emergency Use …
(5 days ago) WebThe FDA's Emergency Use Authorization pathway could allow for Cue's test to be deployed within this respiratory infection season. The Cue Flu + COVID-19 Molecular …
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Cue Health Receives FDA Emergency Use Authorization for Its …
(8 days ago) WebCurrently, Cue Health's products authorized for commercial sale in the United States are the Cue COVID-19 Test Kit and the Cue Mpox Molecular Test Kit, both authorized under …
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Cue Health Receives FDA Emergency Use Authorization …
(9 days ago) WebCue Health Receives FDA Emergency Use Authorization for Its Rapid, Portable, Molecular Point-of-Care COVID-19 Test June 12, 2020 San Diego, CA (June 12, 2020) - Cue …
https://cuehealth.com/about/press/cue-health-receives-fda-emergency-use-authorization-for-its-rapid
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Cue Health Receives FDA Emergency Use Authorization for Its …
(9 days ago) WebCue Health Inc. (“Cue”), a healthcare technology company, announced today that it has received Emergency Use Authorization (“EUA”) from the U.S. Food and Drug …
https://finance.yahoo.com/news/cue-health-receives-fda-emergency-120010060.html
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FDA says to throw out COVID-19 tests made by San …
(8 days ago) WebEarly in the pandemic, the FDA gave Cue Health the industry’s first emergency use authorization, a fast-track approval, for its sleek, 15-minute molecular COVID-19 test.
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Cue Health Evaluating Warning Letter Received from Food and …
(2 days ago) WebCue also received Emergency Use Authorization from the FDA for its molecular Mpox test at the point-of-care. Cue, founded in 2010, holds over 100 patents and is headquartered …
https://finance.yahoo.com/news/cue-health-evaluating-warning-letter-003000614.html
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Cue Health Achieves Groundbreaking Milestone with FDA: First …
(5 days ago) WebSAN DIEGO, CA, June 6, 2023 – Cue Health (Nasdaq: HLTH), a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo …
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Cue Health Achieves Groundbreaking Milestone with FDA: First …
(Just Now) WebSAN DIEGO, June 06, 2023--Cue Health (Nasdaq: HLTH), a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo …
https://finance.yahoo.com/news/cue-health-achieves-groundbreaking-milestone-194900543.html
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FDA Alert: FDA Safety Communication: Do Not Use Cue Health’s …
(9 days ago) WebThe Cue Health COVID-19 Test for Home and Over-the-Counter Use received initial EUA authorization on March 5, 2021, and is authorized for use at home. The FDA issued a …
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Cue Health's Covid-19 tests lead to false results, FDA warns - STAT
(9 days ago) WebT he Food and Drug Administration warned consumers Monday to not use Cue Health’s at-home Covid-19 tests. This follows an FDA warning letter to the company last week that …
https://www.statnews.com/2024/05/13/cue-health-covid-19-test-fda-warning-false-positives/
Category: Food Show Health
COVID tests from Cue Health may not be reliable, FDA urges …
(9 days ago) WebCue Health received Emergency Use Authorizations (EUAs) from the FDA in 2020 and 2021 to sell two COVID-19 tests, one for home use and one for clinical use, the agency …
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Cue Health Applies with FDA for Emergency Use Authorization of …
(9 days ago) WebSAN DIEGO, CA, October 4, 2022 — Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology company that puts diagnostic information at the center of care, today …
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Throw out COVID-19 tests made by Cue Health, FDA warns - MSN
(4 days ago) WebCue Health, headquartered in San Diego, received emergency use FDA authorization for two COVID-19 tests early in the pandemic to help people detect if they were infected with …
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FDA Authorizes Cue Health's COVID-19 Test for At-Home and …
(9 days ago) WebCue is the First to Offer Molecular Diagnostic Testing to Consumers in the U.S. Without a Prescription. - FDA grants Emergency Use Authorization for the Cue COVID-19 Test …
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FDA warns about using over-the-counter COVID-19 tests from …
(Just Now) WebThe FDA first authorized the Cue Health COVID-19 Test in June 2020, "granted revisions to the authorized labeling on Aug. 20, 2020, and subsequently reissued the emergency use …
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Cue Health Makes De Novo Submission to FDA for Full Clearance …
(8 days ago) WebCue’s molecular COVID-19 test, which is authorized by the FDA for home and POC use under an Emergency Use Authorization (EUA), is also currently under de novo review …
https://cuehealth.com/about/press/cue-health-makes-de-novo-submission-to-fda-for-full-clearance-of
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