Click to enlarge. Operating instructions for FlowFlex SARS-CoV-2 Antigen Rapid Test with prefilled extraction buffer tubes. }. -ms-flex-item-align: center; This coronavirus (COVID-19) rapid nose-only test comes in a blue and white pack with the ACON Flowflex brand on it. 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. text-decoration: none; "ItemImage" : "/wcsstore/eBootsStorefrontAssetStore/images/NoImageIcon.jpg", 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. . Some Flowflex tests aren't regulated in the US, the FDA says. 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Flowflex COVID-19 Antigen Home Test documents available for download. Disabled or chronically sick people can claim VAT relief on purchases for personal or domestic use that are applicable to their disability or sickness. Sorry, we're unable to find stores near that location. Copyright The Boots Company PLC. 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 . This FlowFlex antigen test pack involves the most recent innovation in distinguishing proteins guaranteeing it recognizes new traces of the Coronavirus. Flowflex tests that look like this are authorized and available in the US. width: auto; margin-left: 50px; See. 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. Before CNET, she worked in local journalism covering public health issues, business and music. Content on this site is for reference purposes only. This guide tells you how to: prepare the test take a swab sample from. For in vitro diagnostic use only. The FlowFlex Rapid Test Kit is currently the most accurate and affordable test on the market. FlowflexCovid-19 Antigen Home Test Consumer Package Insert. Gardian T3 COVID-19-SARS-CoV-2 Antigen Saliva Self Test (pdf,691kb) text-transform: uppercase; Conversely, the Flowflex SARS-CoV-2 Antigen Rapid Test (ACON Laboratories) showed a higher sensitivity for delta compared with other Ag-RDT kits ( appendix pp 1-2 ). endstream endobj 44 0 obj <>>> endobj 45 0 obj <>/Font<>/ProcSet[/PDF/Text/ImageB]/XObject<>>>/Rotate 90/Type/Page>> endobj 46 0 obj <>stream 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). All components, and step-by-step instructions, needed to test are included. Delivered on weekdays. Image not specified. 2958813. For more information see our delivery help or view our returns policy. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,975kb) (Rapid antigen test) Nasal swab. 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. ACON Laboratories, Inc. is the only legal manufacturer of the FDA EUA Flowflex COVID-19 Antigen Home Test. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. "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. LjV]7@&PNDB}rcPiHN" 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. 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. justify-content: center; Need something more bespoke? View all Flowflex A CE marked rapid lateral flow test 5 pack for the detection of Covid 19 Antigens in nasal swab specimens. 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. Registered VAT number 116300129. .cu-ticker .cu-ticker--container { Order by 10pm (subject to change during promotions), available 7 days a week for 4.95. background: #cc0033; /* Update background colour */ Straightforward and easy to read. For use under an Emergency Use Authorization (EUA) only. Sell it yourself. FlowFlex SARSCoV2 Antigen Rapid Test COVID-19 Get the latest information from the CDC about COVID-19. endstream endobj startxref font-size: .82rem !important; Image not specified. All rights reserved. Detects Active COVID-19 Infection Antigens indicate active disease, find out if you have COVID-19 by performing a painless . . 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. 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. display: block; No app is needed to use the test. Product Description. On occasion, manufacturers may improve or change their product formulas and update their labels. } If you have an ACON Flowflex COVID-19 test, compare the packaging to the image above. Availability is an indication only and is updated every 30 minutes. Boots.com is a trading name of Boots UK Limited. font-weight: 600; 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. Follow the steps outlined below to use FlowFlex TM antigen rapid tests: Wash your hands and disinfect the surface where you will be working. The FDA is working with ACON Laboratories, Inc. to resolve this safety issue. ACON provides rapid diagnostics and healthcare products based on a philosophy of high quality at affordable prices. RESULTS that let you enjoy family time, while worrying less about COVID-19. "catentry_id" : "2676648", Shop now, Save 15% when you spend 30 across selected baby products. padding: 0 1rem 0 0; The Flow flex COVID-19 Antigen Home Test is all you need to determine your family's COVID-19 status. FlowFlex Rapid Antigen Test Kits use new technology in detecting the important protein found in COVID-19. %%EOF Acon FlowFlex SARS-Cov-2 Antigen Rapid Test 25 29,00 . margin: 15px auto; padding: 6px 9px 5px 9px !important; Before you begin the test, it is important to read and follow the detailed instructions in the package insert. The test is available in 1-Pack, 2-Pack and 5-Pack. margin-left: 20px !important; But the same test cannot be "cannot be legally imported, distributed, or used" in the US and should be reported, according to the announcement. 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. 2021 ACON Laboratories, Inc. | All Rights Reserved. .cu-ticker { .cu-ticker .cu-ticker--container .cu-ribbon--text strong { Do not use the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in the dark blue packaging, as shown above. color: rgb(255,255,255); For self-testing use. Future shelf-life expiration date extensions will be communicated as they become available. min-width: 80px; 7.45. EASY TO USE. A rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. 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. DOMC ANTIGNOV TEST NA COVID-19 FLOWFLEX Doporuuje se k samostatnmu proveden rychlho antigennho testu FlowFlex Covid-19. 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 Pickup & Same Day Delivery available on most store items. Acon Flowflex COVID-19 Antigen Home Test A single test Only one test comes in the Acon Flowflex COVID-19 Antigen Home Test box. Get a quote. ACON Laboratories, Inc. is the only legal manufacturer of the FDA EUA Flowflex COVID-19 Antigen Home Test. .cu-ticker .cu-ticker--container .cu-ribbon--text { hKAB-^TFE]+.EAaXbAhTFtQ3E4ZEI)J='p3s?+TkLRn))IeUe ve7xL9(>@9[#tcWbjEYO1 P)s:U_/3|Mk1F-s0+2wf;#: JCY {5i/&_wQxxDB*_r2VDn>)hx]uNwCkB%sRsxGj/oc&OXs R[Smz&ts,qNa+t?g08dV align-items: center; Call us for price match Guarentee! HSA/FSA Eligible Restrictions apply; contact your insurance provider about plan allowances and requirements. Please click here to check the new expiration date using the lot number printed on the test kit box. Before you begin the test, it is important to read and follow the detailed instructions in the package insert. -ms-flex-item-align: center; v2"XD2kKS7a03jK7 E/rl:U8p_ {a The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. } 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. Instore & online. The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. 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. ACCURATE. Refer to the table for the new expiration date using the lot number printed on the test kit box. NO SYMPTOMS Needed - The Flowflex COVID-19 Home Test has been authorized to test patients with or without COVID-19 symptoms. -webkit-box-pack: center; Subscribe to get special offers, free giveaways, and once-in-a-lifetime deals. Incl. - 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 Are you sure you want to remove this product? PRODUCT DETAILS. { Get Back to Sharing Special Moments with Family and Friends. h|]Hausd4/E]XAV7QL>bY}@Xf(Sdy:t`M]uE=Qwp ;!v:e,s*`k^9E 7QynsUiVfaxoo aqR&;l_ZDq.%L9k 9!f 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. BUY FLOWFLEX TEST KIT ONLINE More Tests Available Quick View Named Day Delivery Please log in to your account to add products to your favourites. 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: #fff !important; /* Update text colour colour */ These results have been shared with the FDA. 8 January 2022. The Flowflex SARS-CoV-2 Antigen Rapid Test (self-test) is for self-testing by adults and children above the age of 14. Affordable Easy-to-Use Nasal Swab Test Results in 15 minutes Safe for children as young as 2 years old A video journalist demonstrates how to take a rapid antigen test. All distribution of the recalled Flowflex tests in the US should be reported to ACON and the FDA, according to the announcement. justify-content: center; Blog. align-self: center; . SMALL PACKAGING. Packaged in a white box and given the proper emergency use authorization, the "Flowflex COVID-19 Antigen Home Test" is approved in the U.S. Consumers in possession of the unauthorized test are encouraged by the FDA to dispose of the product and if already used to detect a possible COVID infection, seek an additional test from a federally approved provider. font: 1rem/1.3 "Boots Sharp",Arial,sans-serif !important; font-weight: 300; The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. letter-spacing: .5px; Get Results in just 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. -ms-flex-align: center; Delivery options *Other COVID-19 antigen home tests may require a 2nd test 2-3 days after the first. This item is CE licensed and approved for use by healthcare experts and trained staff including Public Health England. Copyright 2023 NBCUniversal Media, LLC. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. } 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! NO PRESCRIPTION REQUIRED - AUTHORIZED under FDA EUA, for home use.
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