Digital diagnostics company Ellume today announced its rapid, at-home #COVID-19 antigen test has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) | Dec 15
The Ellume COVID-19 Home Test carton
globenewswire.com/news-release/2…
The Ellume COVID-19 Home Test carton
globenewswire.com/news-release/2…
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ellumehealth.com/media/
ellumehealth.com/media/
The Ellume #COVID19 Home Test includes instructions for use, sterile nasal swab with child adapter, a dropper, processing fluid, and analyzer. The Bluetooth®-enabled app walks users through step-by-step instructions to perform the test and receive a result
globenewswire.com/NewsRoom/Attac…
globenewswire.com/NewsRoom/Attac…
Dr Sean Parsons
Founder & CEO and Managing Director of Ellume, a digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumers
ellumehealth.com/about/sean-par…
Founder & CEO and Managing Director of Ellume, a digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumers
ellumehealth.com/about/sean-par…
The Ellume #Covid_19 Home Test connects directly to users’ smartphone, providing for step-by-step instructions and display of test results.
- The test demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above
globenewswire.com/news-release/2…
- The test demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above
globenewswire.com/news-release/2…
KEY FEATURES
Time to result: 15 minutes
Highly accurate
Suitable for asymptomatic & symptomatic testing
Suitable for ages 2+ years
ellumehealth.com/products/consu…
Time to result: 15 minutes
Highly accurate
Suitable for asymptomatic & symptomatic testing
Suitable for ages 2+ years
ellumehealth.com/products/consu…
Australian firm receives FDA approval for 'breakthrough' #COVID test | December 16, 2020, 5.27am
- Stephen Hahn, the head of the FDA, hailed the authorisation as "a major milestone in diagnostic testing for COVID-19".
brisbanetimes.com.au/world/north-am…
- Stephen Hahn, the head of the FDA, hailed the authorisation as "a major milestone in diagnostic testing for COVID-19".
brisbanetimes.com.au/world/north-am…
Ellume #COVID-19 Home Test
Qualitative detection of #SARSCoV2 nucleocapsid antigens from mid-turbinate nasal swabs that are self-collected by an individual age 16 years or older, or are collected by an adult from an individual 2 years of age and older.
fda.gov/media/144457/d…
Qualitative detection of #SARSCoV2 nucleocapsid antigens from mid-turbinate nasal swabs that are self-collected by an individual age 16 years or older, or are collected by an adult from an individual 2 years of age and older.
fda.gov/media/144457/d…
Over-The-Counter Home Test For COVID-19 Gets US Green Light | Dec 15
- Ellume’s test looks for viral proteins shed by #COVID-19, which is different from the gold standard tests that look for the genetic material of the virus.
hosted.ap.org/journalrecord/…
- Ellume’s test looks for viral proteins shed by #COVID-19, which is different from the gold standard tests that look for the genetic material of the virus.
hosted.ap.org/journalrecord/…
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