} But the same test cannot be "cannot be legally imported, distributed, or used" in the US and should be reported, according to the announcement. 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Flowflex COVID-19 Antigen Home Test documents available for download. color: #fff !important; /* Update text colour colour */ Do Not Use Certain ACON Flowflex COVID-19 Tests Free Postage. Flowflex Rapid Covid-19 Antigen Home Test - Vitality Medical Flowflex Antigen Sars-Cov-2 Rapid Covid-19 Test. In this window lateral flow tests, such as Flowflex and Healgen are very effective. 0 Flowflex COVID-19 Antigen Home Test New Shelf-life Extension A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. 2198193. 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. Before sharing sensitive information, make sure you're on a federal government site. FlowFlex Covid-19 Antigen Rapid Test ART. For Self Test and Pro Use. Acon Flowflex COVID-19 Antigen Home Test A single test Only one test comes in the Acon Flowflex COVID-19 Antigen Home Test box. DETECTS ACTIVE COVID-19 INFECTION Antigens indicate active disease, find out if you have COVID-19 by performing a painless nasal swab. All components, and step-by-step instructions, needed to test are included. For the most up-to-date news and information about the coronavirus pandemic, visit the. Makes it the perfect test kit for traveling and testing on the go. For self-testing. FlowFlex SARS-CoV-2 COVID-19 Low Level Nasal Non-Invasive Swab Antigen This test cannot be used for travel. margin: 15px auto; The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. Toggle Nav. :G4IFw74It\hth}. SARS-CoV-2 antigen-detecting rapid tests for the delta variant No app is needed to use the test. 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. Hover to zoom. Subscribe to get special offers, free giveaways, and once-in-a-lifetime deals. Copyright 2023 NBCUniversal Media, LLC. Use Find in store below to see if its in stock near you. Get Results in just 15 Minutes. -ms-flex-align: center; Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. The FDA is concerned about the risk of false results when using this unauthorized test. Get the convenience of Flowflex! Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. While the FlowFlex antigen test is a one-test-per-box package, it's sold at a lower $10 . Get a quote. The 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 directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. Flowflex COVID-19 Antigen Home Test | Flowflex COVID Test Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,975kb) (Rapid antigen test) Nasal swab. FlowFlex COVID-19 Antigen Lateral Flow Test Kits FlowFlex COVID-19 Rapid Test Kits (Single Pack) - Flow Flex Rapid Test TEST CHILDREN AGES 2 and up, who are too young for vaccinations. 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. Delivery options Flowflex Lateral Flow Test SARS-CoV-2 Antigen Rapid - Box of 5 [Self Flowflex One Step Lateral Flow Test Kit | 5 tests | One Step Test for align-self: center; Read more:How to Make Sure Your COVID Test Isn't Fake. Additionally, the FlowFlex Lateral Flow Test Kits has been certified for detecting the Omicron COVID Variant . Please click here to check the new expiration date using the lot number printed on the test kit box. margin-left: 20px !important; This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. How to Make Sure Your COVID Test Isn't Fake, Do Not Sell or Share My Personal Information. FlowflexCOVID-19 Antigen Rapid Home Test Kit The 15-minute, at-home, rapid coronavirus antigen testing kits from FLOWFLEX are a great option for those looking to get fast, accurate results. Flowflex Rapid Tests - Covid-19 Lateral Flow Results in 15 Minutes For employee testing solutions, click here. 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. 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. Flowflex with Video Observation - Azova 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. find out more. To locate an authorized US distributor, please click the button. Flowflex COVID -19 Antigen Home Test - CLIAwaived Inc. text-transform: uppercase; Please log in to your account to add products to your favourites. If you have an ACON Flowflex COVID-19 test, compare the packaging to the image above. Coronavirus antigen detection test system. Flowflex - AusDiagnostics As of this week, the manufacturer said it has not received any reports of "adverse events" related to either test and has issued the recall "out of an abundance of caution.". Can be used on children as young as 2 years old. 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. This coronavirus (COVID-19) rapid nose-only test comes in a blue and white pack with the ACON Flowflex brand on it. This product is temporarily unavailable online. -ms-flex-pack: center; 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. display: -webkit-box; Easy and Affordable Detects New Omicron Strain MHRA Registered Nasal Only Test 98.8% Accuracy. When you use the test, you can see if you carry COVID-19 antigens. 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 Headquartered in San Diego, California, ACON Laboratories makes point-of-care medical diagnostics accessible to people around the world. RESULTS that let you enjoy family time, while worrying less about COVID-19. For self-testing use. 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. 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. FlowFlex Covid-19 Antigen Self-Test - CovCare FlowFlex Rapid Antigen Test Kits use new technology in detecting the important protein found in COVID-19. The FlowFlex Rapid Test Kit is uniquely packaged with its own individual serial number for mass testing and tracing . %%EOF Image not specified. "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. Flowflex SARS-CoV-2 Antigen Rapid Test with Video Observation Services for Travel. >98%, 15-20 . margin-left: 50px; Straightforward and easy to read. DivgX$nGJ3LU-{49MNPQT^UPX#\\?yQ~ FlowFlex ANTIGEN Rapid Individual Test Kit 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 The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. -ms-grid-row-align: center; .cu-ticker .cu-ticker--container .button { 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. -webkit-box-align: center; Basket. padding: 10px !important; font-size: .74rem; Product details A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. Just how accurate are rapid antigen tests? Two testing experts explain text-align: left; .cu-ticker .cu-ticker--container { #text-4156288950 { This test cannot be used for travel. border-radius: 5px; { Menu. The FlowFlex COVID-19 Antigen Home Tests are suitable for medical professionals and the public to use. Sell it yourself. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. 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. 293 0 obj <>stream Please try again or use a different postcode or place name. Blue-boxed Flowflex COVID-19 tests are legally available in Europe under the same name because they're regulated there. 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 ). vce. display: block; Item No. For details of Boots online pharmacy services see. NO PRESCRIPTION REQUIRED - AUTHORIZED under FDA EUA, for home use. Flowflex Antigen Rapid Test Lateral Flow Self-Testing Kit 5 Tests 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 . align-self: center; %PDF-1.6 % text-align: left; Operating instructions for FlowFlex SARS-CoV-2 Antigen Rapid Test with prefilled extraction buffer tubes. width: auto; align-self: center; FlowFlex is a rapid test. color: #cc0033; 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. Never be without your favourite Boots products with our international delivery options. EASY TO USE. )C|$)EYD(a%I8"BcD &8`EItnLN \'l_^wXuA9;zq^:P$KhzYpA #text-4156288950 > * { NEW: FlowFlex COVID-19 Antigen Home Test - CVS Pharmacy For self-testing. font-weight: 300; 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. The tests being recalled come in a blue box and are manufactured by ACON Biotech (Hangzhou) Co., Ltd, which can be seen on the back of the box. 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. - Nasal and Nasopharyngeal swab specimens - Results in 15 minutes - Excellent performance compared to molecular methods } Flowflex at Home Covid Test Kit, 5 Test Pack | Costco COVID-19 rapid lateral flow test kit instructions: ACON Flowflex Flowflex Lateral Flow Test SARS-CoV-2 Antigen pack of 5 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. Terms and ConditionsTerms of Use Privacy Policy, 2022 ACON Laboratories, Inc. 10125 Mesa Rim Road, San Diego CA 92121. Get your results within 15 minutes and make those surrounding you aware of the outcomes, so they can make necessary preparations. 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. padding: 12px !important; Flowflex COVID-19 Antigen Rapid Home Test Kit | Walgreens Usually delivered between 8am and 9pm. margin-left: 20px !important; 2958813. This test is a nasal just swab test, delivers the results in 15 minutes. 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. Do not use the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in the dark blue packaging, as shown above.