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. If the item details above arent accurate or complete, we want to know about it. -ms-flex-item-align: center; justify-content: center; FlowFlex COVID-19 Rapid Test Kits (Single Pack) - Flow Flex Rapid Test - Nasal and Nasopharyngeal swab specimens - Results in 15 minutes - Excellent performance compared to molecular methods COVID-19 rapid antigen self-tests that are approved in Australia font-weight: 600; 267 0 obj
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FlowFlex SARS-CoV-2 COVID-19 Low Level Nasal Non-Invasive Swab Antigen For self-testing use. A rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. color: rgb(255, 255, 255); Flowflex L031-118B5 - COVID Rapid Antigen Home Test Kit, Each . ACON released a side-by-side comparison of the two products hoping to help U.S. consumers differentiate between the recalled test and the one cleared for emergency use. Sorry, we're unable to find stores near that location. March 11, 2022, Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Tests (Self-Testing) in dark blue packaging are a product of ACON Biotech (Hangzhou) Co., Ltd. } ]. If you have questions, please contact customer support at 1 (800) 838 9502. The FlowFlex Rapid Test Kit is uniquely packaged with its own individual serial number for mass testing and tracing . Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens. find out more. Acon FlowFlex SARS-Cov-2 Antigen Rapid Test 25 29,00 . A simple nasal swab makes it convenient and easy to use. Flowflex Covid-19 Antigen Home Test - 1ct : Target Find many great new & used options and get the best deals for 5x Flowflex Rapid Antigen Lateral Flow Covid Tests at the best online prices at eBay! Recepty.cz Blesk pro eny Maminka.cz eny.cz Reflex.cz E15.cz FITweb.cz Auto.cz iv.cz. Flowflex COVID-19 Antigen Rapid Home Test Kit | Walgreens For employee testing solutions, click here. Content on this site is for reference purposes only. FDA Recalls 200,000 Unauthorized Flowflex COVID Rapid Tests - NBC New York "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. .cu-ticker .cu-ticker--container .cu-ribbon--text { A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. ACON Laboratories, Inc. is the only legal manufacturer of the FDA EUA Flowflex COVID-19 Antigen Home Test. 5x Flowflex Rapid Antigen Lateral Flow Covid Tests | eBay Critical Information When & Where You Need It. A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. At-home tests and the omicron variant. Subscribe to receive exclusive deals, instructional content & much more. } -webkit-box-pack: center; HSA/FSA cards can be accepted in-store but not on Target.com. 2958813. Flowflex with Video Observation - Azova For self-testing use. Information on how to contact ACON and the FDA can be found at the bottom of the recall announcement. COVID-19 rapid lateral flow test kit instructions: ACON Flowflex width: auto; No app is needed to use the test. 11 Rapid At-Home Covid-19 Testsand Where to Find Them | WIRED ACON Laboratories, Inc. is the only legal manufacturer of the FDA EUA Flowflex COVID-19 Antigen Home Test. For in vitro diagnostic use only. How Accurate are the FlowFlex COVID Tests? Bloom Labs The ACON Laboratories Flowflex COVID-19 Antigen Home Test, authorized by the FDA on October 4, 2021, is not the subject of this Safety Communication and can continue to be used. 1.50 or free if you spend 15 or more from your choice of 2,200 stores. %PDF-1.6
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EASY TO USE. Your personal data will be used to support your experience throughout this website, to manage access to your account, and for other purposes described in our privacy policy. This product now has effective expiration date of November 2023. Get the convenience of Flow flex! 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For Self Test and Pro Use. @media all and (max-width: 850px) { margin-left: 50px; "ItemImage" : "/wcsstore/eBootsStorefrontAssetStore/images/NoImageIcon.jpg", Flowflex COVID-19 Antigen Home Test Package Insert Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) font-weight: 600; color: inherit; Blog. It is intended for self-testing use. } padding: 0; Easy and Affordable Detects New Omicron Strain MHRA Registered Nasal Only Test 98.8% Accuracy. In comparison with B.1.610, the delta variant, like the alpha, beta, and gamma variants, presented higher sensitivity. Please use this overlay to check for product availability. text-decoration: none; Before CNET, she worked in local journalism covering public health issues, business and music. color: rgb(255,255,255); Subscribe to get special offers, free giveaways, and once-in-a-lifetime deals. Delivered on weekdays. A video journalist demonstrates how to take a rapid antigen test. If your Flowflex test box looks like this, it's being recalled. 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. Flowflex is FDA Emergency Use Authorized (EUA) for self-testing without the need for a prescription. 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 test is available in 1-Pack, 2-Pack and 5-Pack. Testing for antigens is another way to determine if you contracted COVID-19, especially if you are asymptomatic. The Flowflex SARS-CoV-2 Antigen Rapid Test (self-test) is for self-testing by adults and children above the age of 14. Ensure you are aware this will not provide you with a certificate and your results will not be verified. For self-testing. How To Use - Flow Flex Rapid Test How To Use Watch how to use our antigen test kit How To Use OUR Antigen Rapid Test Please take the time to watch our short video showing how to use our test kit. The Flowflex COVID-19 Antigen Home Test is all you need to determine your familys COVID-19 status. Headquartered in San Diego, California, ACON Laboratories makes point-of-care medical diagnostics accessible to people around the world. TEST CHILDREN AGES 2 and up, who are too young for vaccinations. Fast Accurate Easy to use Reliable CE marked. 3.95 - choose a weekday within the next 14 days for delivery. Very high sensitivity. box-sizing: border-box; Are you sure you want to remove this product? 2021 ACON Laboratories, Inc. | All Rights Reserved. 6x Covid-19 Flowflex Rapid Antigen Lateral Flow Covid 19 Home Test lft. Since the launch of its Flowflex COVID-19 Antigen Home Test, ACON Laboratories, Inc. has continued testing for product stability to extend the shelf-life. Before you begin the test, it is important to read and follow the detailed instructions in the package insert. The Flowflex COVID-19 Rapid Antigen Test is the most accurate rapid antigen test on the market*. Availability is an indication only and is updated every 30 minutes. Flowflex Lateral Flow Test SARS-CoV-2 Antigen pack of 5 Call Us 01254 686 500. } align-self: center; The Flow flex COVID-19 Antigen Home Test is all you need to determine your family's COVID-19 status. For general use. Acon Biotech Hangzhou Flowflex SARS-CoV-2 Antigen Rapid Test 25 ks }, We are here to help if you have a question. Image not specified. For use under an Emergency Use Authorization (EUA) only. Instore & online Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. 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. Self-test for detection of SARSCoV2 antigen in individuals with suspected COVID19. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) RM 11.90 RM 9.90 Product Specification Test time: 15 minutes Sensitivity: 97.1% Specificity: 99.5% Sample type: Nasal Swab Storage Condition: 2c to 30 c Catalog: L031-118M5 Request for Quote (Orders above 300 units) First Name Last Name Email Address Contact Number Company Name (If Any) Sign up to receive email updates on medical device recalls, safety communications, and other safety information. FlowFlex COVID-19 Rapid Antigen Home Test Kits for Sale | Shop FlowFlex Easily fits in a purse or a small bag. Boots.com is a trading name of Boots UK Limited. Do Not Use Certain ACON Flowflex COVID-19 Tests Need Help? 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. color: #cc0033; display: flex; Click OK to extend your time for an additional 20 minutes. %%EOF
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rFcT Q@&-Va%*8*0-* While the FlowFlex antigen test is a one-test-per-box package, it's sold at a lower $10 . padding: 6px 9px 5px 9px !important; margin: 15px auto; The Flowflex COVID-19 Antigen Home Test is all you need to determine your familys Covid-19 status, whether symptoms are present or not. Now you can take the FlowFlex SARS-CoV-2 Antigen Rapid Test with you when you travel and take the test from wherever you are to meet re-entry COVID-19 testing requirements for the United States. See. RESULTS that let you enjoy family time, while worrying less about COVID-19. } In order to buy non-prescription medicines you must be a registered user of our site as we are obliged to record your transaction history. 0
Please click here to check the new expiration date using the lot number printed on the test kit box. Flowflex Rapid Tests - Covid-19 Lateral Flow Results in 15 Minutes If you've had a COVID-19 test with one of the recalled antigen tests within two weeks, consider testing again, the FDA said. Item No. 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. 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, https://www.boots.com/covid-19-testing/pre-departure-to-uk-covid-19-travel-testing, Find out more about international delivery, Flowflex Antigen Rapid Test Lateral Flow Self-Testing Kit 5 Tests. text-align: left; Sell it yourself. { FlowFlex Covid-19 Antigen Self-Test - CovCare margin-left: 20px !important; Click to enlarge. Rapid antigen tests show lower sensitivity for Omicron than for earlier Shop now, Save 15% when you spend 30 across selected baby products. Operating instructions for FlowFlex SARS-CoV-2 Antigen Rapid Test with prefilled extraction buffer tubes. 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner. We are pleased to announce that the request to extend the Flowflex ACON Laboratories, Inc., has become aware that counterfeit versions of its FDA-authorized Flowflex COVID-19 Antigen Home Tests in the 1 Test/ kit box configuration marked as Lot# COV2010030 and COV2030016 are being illegally distributed in the United States through 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, Terms and ConditionsTerms of Use Privacy Policy, 2022 ACON Laboratories, Inc. 10125 Mesa Rim Road, San Diego CA 92121. Amazon.com: Flowflex Covid-19 Rapid Test Kit Researchers have demonstrated that an infected individual will test positive on a PCR test one to two days before an antigen test. 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. For in vitro diagnostic use only. Please click here to check the new expiration date using the lot number printed on the test kit box. Panodyne SARS-CoV-2 Antigen Rapid Covid-19 Test 15 Minutes 24.50 4.49 Select options Flowflex and Panodyne COVID Rapid Test Kit (nasopharyngeal swab/oropharyngeal swab) with CE certification and intended for Health Professional Use to assist in the identification of the presence of the COVID-19 (Coronavirus) virus in the bloodstream. 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. 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. For more information see our delivery help or view our returns policy. #text-15297007 { Delivery options Since the launch of its Flowflex COVID-19 Antigen Home Test, ACON Laboratories, Inc. has continued testing for product stability to extend the shelf-life. .cu-ticker { The FlowFlex COVID-19 Antigen Home Tests are suitable for medical professionals and the public to use. -ms-flex-item-align: center; PDF Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) Added coconut oil to cheap coffee before keto made it cool. Here's a quick overview of how it works: My Account. If you have specific healthcare concerns or questions about the products displayed, please contact your licensed healthcare professional for advice or answers. Get the convenience of Flowflex! Small enough to be a stocking stuffer. iHealth COVID-19 Antigen Rapid Test, 2 Tests per Pack,FDA EUA Authorized OTC At-home Self Test, Results in 15 Minutes with Non-invasive Nasal Swab, Easy to . 8.99. - Product Code QKP: Product: FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test: Code Information: UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023: Recalling Firm/ Manufacturer: Migo Trading LLC 831 Laca St Dayton NV 89403-6394