investorrelations@lucirahealth.com So we can all stay safe and in control of our own health, always. Can be completed in 30 minutes or less. Testing may be key to ending the COVID pandemic, Millions of rapid COVID-19 tests still unused, according to federal data. Lucira COVID-19 & Flu Test - All You Need to Answer "Is it Covid or the Flu?" We are doctors, nurses, nurse practitioners, pharmacists, and physician assistants who are passionate about providing patient care. $10 for a single test and $225 for a 25-pack (discounted from $350). Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. We know that seeing a doctor often isn't easy on your schedule, wallet, or peace of mind. List of authorized medical devices other than testing, List of medical devices for expanded use in relation to COVID-19, List of medical devices for exceptional import and sale, Authorization of COVID-19 testing devices, Understanding the "testing information" column, Self-collection of nose and throat swab samples for SARS-CoV-2 antigen testing, report your concern directly to Health Canada, COVID-19 rapid antigen testing devices that use serial testing for individuals without symptoms: Notice to industry, List of Medical Devices for Expanded Use in Relation to COVID-19, the way samples should be collected (nasal or saliva), who should be collecting them (health professional or individual), where the test is done (lab, point-of-care or at home). Molecular tests are more sensitive than antigen tests because they amplify critical parts of the viral target. It is a molecular test that amplifies the viruss genetic material while the test is running just like PCR lab tests. Positive results are indicative of the presence of SARS-CoV-2. Lucira said that it will prioritise the distribution of its Covid-19 & Flu Test in Canada, along with the current Covid-19 test. The ready light will blink until a positive or negative green light is illuminated within 30 minutes. Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/c3d39964-d38a-4986-afcb-472da6f8300c, https://www.globenewswire.com/NewsRoom/AttachmentNg/9dd32dc0-c1ef-4bd0-b819-9a71bcfa0222, https://www.globenewswire.com/NewsRoom/AttachmentNg/313060d2-cba9-459c-a995-abe5d0ea8ceb, 1985 - 2023 BioSpace.com. The enhancements that you chose aren't available for this seller. Promis Diagnostics EarlyTect BCD test gets FDA breakthrough device status, Quest Diagnostics to acquire Haystack Oncology for $450m, GE HealthCare introduces macrocyclic MRI agent Pixxoscan, Intuitive secures FDA approval for da Vinci SP surgical system for prostatectomy, HelpMeSee rolls out simulation-based training for cataract surgery, Nuvo Group plans to go public in US through merger with LAMF. We offer two over-the-counter COVID-19 Test Kits, the Flowflex COVID-19 Antigen Home Test and the Lucira Check It COVID-19 Test Kit. We are proud our self-test was the first one authorized for use within this vast country. Canada M6K 3E7. This timely action is expected to help Canadians accurately test at-home in advance of flu season, keep more people out of the emergency departments, and provide a rapid treatment pathway.. Lucira Check It COVID-19 Test Kit is a high performing molecular test, equivalent to other tests accepted by most travel destinations. We appreciate Health Canada for its careful and thorough assessment of the Lucira COVID-19 & Flu Test. Health Canada silent on COVID-19 home tests as other countries - CBC The test is FDA-authorized under an Emergency Use Authorization. Lucira Check It COVID-19 Test Kit is a high performing molecular test, equivalent to other tests accepted by most travel destinations. Health Canada said last year it wouldn't consider at-home tests due to concerns about accuracy, though it later changed that stance. Molecular tests, including PCR tests completed in a lab and the PCR-quality Lucira Home Test Kits, detect the genetic material of the virus that causes COVID-19, while antigen tests detect proteins on the surface of the virus. Media Contact The Flowflex COVID-19 Antigen Home Test allows for sample self-collection by individuals ages 14 and older. Variants can impact the performance of a test. The batteries are inserted in the device and the sample vial is placed in the test unit. EMERYVILLE, Calif.--(BUSINESS WIRE)--Lucira Health, Inc. (Nasdaq: LHDX), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, today announced that Health Canada issued an Authorization with Conditions for the LUCIRA CHECK IT COVID-19 test kit. If you take a sample in a different way, your test result may be inaccurate. Indicated for all people aged 14 years or older and for children as young as two years old when samples are collected by an adult. Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.
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