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Features: Detects active COVID-19 infection Copyright 2023 NBCUniversal Media, LLC. This test kit is approved to be used in home. The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). Flowflex COVID-19 Home Test, FDA authorized Antigen test that requires only 1 test, results in 15 minutes, Nasal Swab. padding: 6px 9px 5px 9px !important; As of November 18, 2022, the expiration date of the Flowflex COVID-19 Antigen Home Test has been extended by 9 months. "catentry_id" : "2676648", %%EOF } 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner. The FlowflexCOVID-19 Antigen Rapid Home Test Kit isa great option for those looking for quick results. { The unauthorized test has a dark blue box with white lettering and symbols in the lower right corner of the box, including the letters CE and the name ACON Biotech (Hangzhou) Co., Ltd. identified on the outer box label. %PDF-1.6 % 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. To locate an authorized US distributor, please click the button. 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. -webkit-box-sizing: border-box; LjV]7@&PNDB}rcPiHN" 267 0 obj <>/Filter/FlateDecode/ID[<37EBE39B4A765A85C7911C0DFB92A584><2F8B2D9AC0570041A82CDA2C5E51F00F>]/Index[43 251]/Info 42 0 R/Length 595/Prev 431472/Root 44 0 R/Size 294/Type/XRef/W[1 3 1]>>stream } ]. >98%, 15-20 . The .gov means its official.Federal government websites often end in .gov or .mil. } 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. The covid-19 antigen home test nasal swab is gentle and non-invasive, allowing users to get a test sample with minimal discomfort. } align-self: center; -ms-flex-item-align: center; Recepty.cz Blesk pro eny Maminka.cz eny.cz Reflex.cz E15.cz FITweb.cz Auto.cz iv.cz. The U.S. Food and Drug Administration (FDA) is warning people not to use certain ACON COVID-19 tests, a product of ACON Biotech (Hangzhou) Co., Ltd. People should not use the ACON Biotech test named Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) that is packaged in a dark blue box (see images below). @media all and (max-width: 767px) { Registered VAT number 116300129. Acon Flowflex COVID-19 Antigen Home Test A single test Only one test comes in the Acon Flowflex COVID-19 Antigen Home Test box. NO PRESCRIPTION REQUIRED - AUTHORIZED under FDA EUA, for home use. Approved globally by 40+ countries; European Union, China, United Kingdom, Singapore, Australia, Canada and more. 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. .cu-ticker .cu-ticker--container .cu-ribbon--text { All rights reserved, The Food and Drug Administration issued a recall, Mysterious Cases of Men Found Dead After Leaving NYC Gay Bars Ruled Homicides: ME, Actor Tom Sizemore, of Saving Private Ryan,' Dies at 61, Viral Kids' Star Ms. Rachel Is Taking a Break From Social Media After Backlash Over Co-Star Who Uses They/Them Pronouns, This 26-Year-Old Pays $0 to Live in a Luxury Tiny Home' She Built for $35,000 in Her Backyard Take a Look Inside, NYC Winter Storm: 12 Hours of Rain, 40 MPH Winds and Snow Expected; See Timing Here, Columbia Dumps SAT Admissions Requirement for Good. Next Day Delivery Need Help? -ms-grid-row-align: center; width: auto; 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. ACON Laboratories, Inc. has initiated a recall for all unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Tests (Self-Testing) tests that were distributed in the U.S. Shop now, Save 15% when you spend 30 across selected baby products. color: inherit; No app is needed to use the 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. For use under an Emergency Use Authorization (EUA) only. For use under an Emergency Use Authorization (EUA) only. The FlowFlex COVID-19 Antigen Home Tests are suitable for medical professionals and the public to use. 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. .cu-ticker .cu-ticker--container .button:hover { hXYOH+e!B 03"!,$Jj[m;EEJvQK %#a h rFcT Q@&-Va%*8*0-* Image not specified. Basket. Small enough to be a stocking stuffer. color: #cc0033; 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. Flowflex is FDA Emergency Use Authorized (EUA) for self-testing without the need for a prescription. This item is CE licensed and approved for use by healthcare experts and trained staff including Public Health England. The FlowFlex COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected direct anterior nasal swab samples from individuals aged two years or older. While the FlowFlex antigen test is a one-test-per-box package, it's sold at a lower $10 . 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. As of November 18, 2022, the expiration date of the Flowflex COVID-19 Antigen Home Test has been extended by 9 months. Detects Active COVID-19 Infection Antigens indicate active disease, find out if you have COVID-19 by performing a painless . This guide tells you how to: prepare the test take a swab sample from. The FlowFlex Rapid Test Kit uses the latest patented technology in detecting proteins ensuring that it can detect new strains of the COVID-19 virus. For use under an Emergency Use Authorization (EUA) only. One-Step rapid Lateral Flow Test for COVID-19 SARS-CoV-2 Antigen, please read the patient information leaflet ; Registered with MHRA and CE Marked and duly approved under Coronavirus Test Devices Approvals (CTDA) Amendment Regulations 2021 ; Flowflex tests are manufactured and packaged in a sterile environment 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. Sorry, we're unable to find stores near that location. ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants to ensure that the Flowflex COVID-19 Antigen Home Test can detect them. Headquartered in San Diego, California, ACON Laboratories makes point-of-care medical diagnostics accessible to people around the world. A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. For the most up-to-date news and information about the coronavirus pandemic, visit the. .cu-ticker { Acon FlowFlex SARS-Cov-2 Antigen Rapid Test 25 29,00 . margin-left: 20px !important; We are pleased to announce that the request to extend the Flowflex COVID-19 Antigen Home Test shelf-life from 12 months to 21 months, when stored at 36-86F (2-30C),has been granted. The FlowFlex Rapid Test Kit is currently the most accurate and affordable test on the market. display: -ms-flexbox; letter-spacing: .5px; Patients will have moderate to high viral loads about 3 days before symptoms start until between 7 and 10 days after symptoms start. Back in January 2022, the FDA recalled a counterfeit version called Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) that hasn't been authorized for sale in the US. It does not differentiate between SARS-CoV and SARS-CoV-2. If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100. Product Description. The Food and Drug Administration issued a recall late last month for "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)," a product sold at an unknown number of pharmacies and distributed by . "ItemImage467" : "/wcsstore/eBootsStorefrontAssetStore/images/NoImageIcon.jpg", This coronavirus (COVID-19) rapid nose-only test comes in a blue and white pack with the ACON Flowflex brand on it. 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. 7.45. *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 8 January 2022. @media all and (max-width: 850px) { .cu-ticker .cu-ticker--container .button { Product contents: 5 Test Cassettes 5 Extraction Buffer Tubes 5 Waste Bags 5 Nasal Swabs Product Insert in both Traditional Chinese and English The Flow flex COVID-19 Antigen Home Test is all you need to determine your family's Covid-19 status, whether symptoms are present or not. The earliest delivery date for these orders will be shown at the checkout. display: -webkit-box; 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. 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. 8.99. At least, if you got it in the US. 2958813. border: 1px solid #fff; } Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test as shown in the Porton Down. Item No. K proveden testu by Acon Biotech Hangzhou Flowflex SARS-CoV-2 Antigen Rapid Test 5 ks Researchers have demonstrated that an infected individual will test positive on a PCR test one to two days before an antigen test. Flowflex tests that look like this are authorized and available in the US. Additionally, the FlowFlex Lateral Flow Test Kits has been certified for detecting the Omicron COVID Variant . For in vitro diagnostic use only. text-align: left; This test is a nasal just swab test, delivers the results in 15 minutes. Now everyone can enjoy the family for the upcoming holidays. padding: 6px 9px 5px 9px !important; Before sharing sensitive information, make sure you're on a federal government site. For details of Boots online pharmacy services see. -webkit-box-pack: center; 3M Aura 9320+ FFP2 Respirator Face Mask. } We recommend that you do not rely solely on the information presented on our Web or Mobile sites and that you review the product's label or contact the manufacturer directly if you have specific product concerns or questions. Use Find in store below to see if its in stock near you. Shop COVID-19 Antigen Rapid Home Test Kit and read reviews at Walgreens. The Flowflex and Healgen tests pick up moderate to high viral loads. display: flex; Please click here to check the new expiration date using the lot number printed on the test kit box. } -webkit-box-align: center; Easy-to-use nasal swab test Can be used to test children as young as 2 years old For use with and without COVID-19 symptoms Results in 15 minutes No need to send off to a lab to obtain results Flowflex Antigen Sars-Cov-2 Rapid Covid-19 Test. .cu-ticker .cu-ticker--container { -ms-flex-item-align: center; -webkit-box-pack: center; FlowFlex SARSCoV2 Antigen Rapid Test COVID-19 Get the latest information from the CDC about COVID-19. Hover to zoom. The FDA is concerned about the risk of false results when using this unauthorized test. align-self: center; HSA/FSA cards can be accepted in-store but not on Target.com. TEST ONCE, unlike other tests, no need to retest a couple of days after the 1st test, unless new symptoms appear! An instruction video is located at FlowflexCOVID.com. 0 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. 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. Incl. A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. 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. Blog. 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. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. 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. Jessica is a writer on the Wellness team with a focus on health news. Boots.com is a trading name of Boots UK Limited. H/NzYjzjV]2"iy +>C$Iq$y;my}AdQbQgeF$}e\M,q8"B^c]#g2iE>La4,xW%[Otucj(S-DE*qLv {x 8Vv2o/70Mz({J+`] 4T Read more:How to Make Sure Your COVID Test Isn't Fake. 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. This product is temporarily unavailable online. Your session is about to timeout due to inactivity. For self-testing. justify-content: center; .cu-ticker .cu-ticker--container .cu-ribbon--icon { v2"XD2kKS7a03jK7 E/rl:U8p_ {a Refer to the table for the new expiration date using the lot number printed on the test kit box. Get your results within 15 minutes and make those surrounding you aware of the outcomes, so they can make necessary preparations. Sell it yourself. Instore & online. The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. Ensure you are aware this will not provide you with a certificate and your results will not be verified. Flowflex Antigen Rapid Lateral Flow 5 TESTS Covid 19 Home Testing UK Pharmacy. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. If your Flowflex test box looks like this, it's being recalled. Picture 1 of 3. This product now has effective expiration date of November 2023. display: block; Blue-boxed Flowflex COVID-19 tests are legally available in Europe under the same name because they're regulated there. NO SYMPTOMS Needed - The Flowflex COVID-19 Home Test has been authorized to test patients with or without COVID-19 symptoms. 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). *Other COVID-19 antigen home tests may require a 2nd test 2-3 days after the first. Future shelf-life expiration date extensions will be communicated as they become available. A common rapid at-home COVID test has become the subject of a recent product recall over concerns the antigen test hasn't received proper U.S. authorization. } 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. If it's been more than two weeks since you've used one of the tests and you don't have any symptoms, it's not necessary to test again, per the FDA. UK APPROVED Rapid Covid-19 Lateral Flow Antigen Test Kits, Mon - Fri: 9am - 6pm | Weekends: 10am - 4pm. Coronavirus antigen detection test system. Subscribe to receive exclusive deals, instructional content & much more. } @media all and (max-width: 320px) { margin: 0; See. margin: 0 auto; 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) } 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. 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. Get Back to Sharing Special Moments with Family and Friends. Free Postage. (It came in a dark. -ms-flex-align: center; Get the convenience of Flow flex! Never be without your favourite Boots products with our international delivery options. #text-15297007 { 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. color: rgb(255,255,255); text-align: left !important; COVID-19 Antigen Home Test | Walgreens Skip to main content Extra 15% off $40&plus; vitamins Weekly Ad Up to 50% off clearance Menu Find a Store Prescriptions Back Prescriptions Refills Order Status Records font-weight: 300; The Flowflex COVID-19 Antigen Home Test is all you need to determine your familys COVID-19 status. Follow the steps outlined below to use FlowFlex TM antigen rapid tests: Wash your hands and disinfect the surface where you will be working. DivgX$nGJ3LU-{49MNPQT^UPX#\\?yQ~ The SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms. padding: 12px !important; Testing for antigens is another way to determine if you contracted COVID-19, especially if you are asymptomatic. padding: 0; 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. This FlowFlex antigen test pack involves the most recent innovation in distinguishing proteins guaranteeing it recognizes new traces of the Coronavirus. For self-testing use. This may not be available during public holidays or weekends in between public holidays. Want CNET to notify you of price drops and the latest stories? Easily fits in a purse or a small bag.