flowflex antigen rapid test

Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. How to Use FlowFlex Home COVID-19 Tests. (It came in a dark. For employee testing solutions, click here. Watch on In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and. #text-4156288950 { $10 from CVS $9. Flowflex Covid-19 Antigen Home Test Consumer Package Insert, Flowflex Covid-19 Antigen Home Test Consumer Package Insert (Spanish), Flowflex Covid-19 Antigen Home Test Fact Sheet for Healthcare Professionals, Flowflex Covid-19 Antigen Home Test Healthcare Provider Package Insert, Flowflex Covid-19 Antigen Home Test Distributor Sell Sheet, Flowflex Covid-19 Antigen Home Test Quick Reference Instructions (English), Flowflex Covid-19 Antigen Home Test Quick Reference Instructions (Spanish), For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19, Phone: 1-858-875-8000 Fax: 1-858-200-0729 Email: info@aconlabs.com. This item is CE licensed and approved for use by healthcare experts and trained staff including Public Health England. If you have specific healthcare concerns or questions about the products displayed, please contact your licensed healthcare professional for advice or answers. *Please note the NHS portal does not accept results/QR code reports from consumer bought tests, it can only be used for free NHS supplied tests More Product Information 47 Reviews "COVID-19 Antigen tests in the U.S. market that lack FDA approval, clearance, or authorization can pose significant risk since they may lead to inaccurate test results, including false negative or false positive test results," a statement from the manufacturer said this week. The FlowflexCOVID-19 Antigen Rapid Home Test Kit isa great option for those looking for quick results. } Usually delivered between 8am and 9pm. This test procedure overview does not replace the package insert. Flowflex Antigen Sars-Cov-2 Rapid Covid-19 Test. This product is temporarily unavailable online. padding: 10px !important; .cu-ticker .cu-ticker--container { )C|$)EYD(a%I8"BcD &8`EItnLN \'l_^wXuA9;zq^:P$KhzYpA [ 8 January 2022. If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you toreport the problem through the MedWatch Voluntary Reporting Form. Small enough to be a stocking stuffer. .cu-ticker .cu-ticker--container .cu-ribbon--text strong { View all Flowflex A CE marked rapid lateral flow test 5 pack for the detection of Covid 19 Antigens in nasal swab specimens. For the most up-to-date news and information about the coronavirus pandemic, visit the. padding: 12px !important; -webkit-transition: all 0.2s ease-in-out; The highest overall sensitivity for all SARS-CoV-2 used was shown by Flowflex, which detected Omicron with slightly higher sensitivity than Delta variant but lower than Alpha, Beta, Gamma, and. FlowflexCovid-19 Antigen Home Test Consumer Package Insert. The Food and Drug Administration issued a recall late last month for FlowflexSARS-CoV-2 Antigen Rapid Test (Self-Testing)," a product sold at an unknown number of pharmacies and distributed by local health officials. The Flowflex COVID-19 Antigen Home Tes t is an easy-to-use, rapid nasal swab test that detects an active COVID-19 infection in 15 minutes. The FlowFlex Rapid Lateral Flow Antigen Test Kit uses the latest patented technology to detect proteins, ensuring that it can detect new strains of the COVID-19 virus. These results have been shared with the FDA. Critical Information When & Where You Need It. font-size: .7rem !important; See. Headquartered in San Diego, California, ACON Laboratories makes point-of-care medical diagnostics accessible to people around the world. -ms-grid-row-align: center; color: rgb(255,255,255); Flowflex COVID-19 Home Test, FDA authorized Antigen test that requires only 1 test, results in 15 minutes, Nasal Swab. -ms-flex-item-align: center; -ms-flex-align: center; } Medical news, pregnancy topics and health hacks that don't cost money. Instore & online. STATEMENT ON THE NEW OMICRON VARIANTS (BQ.1.1, BQ.1, XBB.1.5, XBB, and BF.7), Flowflex COVID-19 Antigen Home Test New Shelf-life Extension, PUBLIC NOTICE OF COUNTERFEIT FLOWFLEX COVID-19 TEST KITS, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Can be used to test children as young as 2 years old, For use with and without COVID-19 symptoms, No need to send off to a lab to obtain results, Compact packaging for On-The-Go testing. There've been no reports of adverse events, but because the duplicate tests haven't been tested or authorized by the FDA, there's a possibility of a false negative or false positive result. Fast Accurate Easy to use Reliable CE marked Specimen: Anterior nasal swab specimens Test time: Results at 15 mins Shelf life: 24 months Storage temperature: 2-30oC Accuracy: 98.8% The FlowFlex Rapid Test Kit uses patented technology developed by Acon Laboratories, a leading global diagnostics company, to detect new strains of the COVID-19 virus. The recall of the test, which the government estimates has 200,000 in U.S. circulation, may confuse consumers between two Flowflex branded antigen tests. @media all and (max-width: 320px) { justify-content: center; Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. The FDA is working with ACON Laboratories, Inc. to resolve this safety issue. The Flowflex COVID-19 Rapid Antigen Test enables you to effectively detect COVID-19, including the Omicron variant, with 98.8% accuracy in less than 15 minutes. Please click here to check the new expiration date using the lot number printed on the test kit box. If the item details above arent accurate or complete, we want to know about it. .cu-ticker .cu-ticker--container .cu-ribbon--text { .cu-ticker { Registered office: Nottingham NG2 3AA.Registered in England: company number 928555. 2023 CNET, a Red Ventures company. The Flowflex COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. font: 1rem/1.3 "Boots Sharp",Arial,sans-serif !important; }, We are here to help if you have a question. Acon Flowflex COVID-19 Antigen Home Test A single test Only one test comes in the Acon Flowflex COVID-19 Antigen Home Test box. color: #fff !important; /* Update text colour colour */ U.K. Government validated at Public Health England, Porton Down Laboratories. min-width: 80px; A positive test should be repeated using a RT-PCR test for . Easy Covid-19 antigen home test step-by-step instructions ensure that the self-testing is taken . SMALL PACKAGING. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. Get a quote. Copyright 2023 NBCUniversal Media, LLC. All distribution of the recalled Flowflex tests in the US should be reported to ACON and the FDA, according to the announcement. } Before you begin the test, it is important to read and follow the detailed instructions in the package insert. Save 15% when you spend 30 across selected baby products. PRODUCT DETAILS. "Attributes" : { }. The manufacturer of the Flowflex tests, ACON Laboratories, said it was aware of the "unauthorized, adulterated and misbranded counterfeit product" and issued a recall order on Jan. 9. For in vitro diagnostic use only. 43 0 obj <> endobj Flowflex COVID-19 Home Test, FDA authorized Antigen test that requires only 1 test, results in 15 minutes, Nasal Swab. -webkit-box-sizing: border-box; padding: 6px 9px 5px 9px !important; Self-test for detection of SARSCoV2 antigen in individuals with suspected COVID19. VAT: 25.79. Should you need a verified test with a certificate, please visit https://www.boots.com/covid-19-testing/pre-departure-to-uk-covid-19-travel-testing. My Account. The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. While the Flowflex test that comes in a white box with the full name "Flowflex COVID-19 Antigen Home Test" is safe to use (it has an emergency use authorization from the FDA), there's a. Basket. This FlowFlex antigen test pack involves the most recent innovation in distinguishing proteins guaranteeing it recognizes new traces of the Coronavirus. Flowflex SARS-CoV-2 Antigen Rapid Test with Video Observation Services for Travel. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. ACON provides rapid diagnostics and healthcare products based on a philosophy of high quality at affordable prices. The unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. 7.45. Sell it yourself. @media all and (max-width: 850px) { Please Be Aware Postal Delays Are Possible Dismiss, Buy Covid 19 Test Kits Online Direct From UK Distributor, FlowFlex COVID-19 Rapid Test Kits (Single Pack), FlowFlex COVID-19 Rapid Test Kits (Multi Pack x 5), FlowFlex COVID-19 Rapid Test Kits (Multi Pack x 25). endstream endobj startxref 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner. -webkit-box-align: center; @media all and (max-width: 991px) { As of November 18, 2022, the expiration date of the Flowflex COVID-19 Antigen Home Test has been extended by 9 months. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Safe for children as young as 2 years old. display: -webkit-box; An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication, report the problem through the MedWatch Voluntary Reporting Form, Report any problems you experience with the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) to the FDA, including suspected false results.

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