background: #cc0033; /* Update background colour */ 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. Patients will have moderate to high viral loads about 3 days before symptoms start until between 7 and 10 days after symptoms start. 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. 12 Months. Ensure you are aware this will not provide you with a certificate and your results will not be verified. K proveden testu by Acon Biotech Hangzhou Flowflex SARS-CoV-2 Antigen Rapid Test 5 ks 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. } ]. 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. Terms and ConditionsTerms of Use Privacy Policy, 2022 ACON Laboratories, Inc. 10125 Mesa Rim Road, San Diego CA 92121. For general use. Children under the age of 14 may need adult supervision. v2"XD2kKS7a03jK7 E/rl:U8p_ {a Please click here to check the new expiration date using the lot number printed on the test kit box. 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. @media all and (max-width: 850px) { Critical Information When & Where You Need It. Basket. Find peace of mind with Flowflex! 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. } Future shelf-life expiration date extensions will be communicated as they become available. display: -webkit-box; color: inherit; A rapid test for the detection of COVID-19 antigens in nasal specimens. Now everyone can enjoy the family for the upcoming holidays. ACON Laboratories, Inc. is the only legal manufacturer of the FDA EUA Flowflex COVID-19 Antigen Home Test. 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. For self-testing. Menu . Jessica is a writer on the Wellness team with a focus on health news. min-width: 80px; The company made the announcement about the other Flowflex tests in January, and the FDA published it on Friday. -ms-flex-item-align: center; 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. No app is needed to use the test. This FlowFlex antigen test pack involves the most recent innovation in distinguishing proteins guaranteeing it recognizes new traces of the Coronavirus. The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. This test procedure overview does not replace the package insert. 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. HSA/FSA cards can be accepted in-store but not on Target.com. color: rgb(255, 255, 255); justify-content: center; } All rights reserved. For in vitro diagnostic use only. 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. Please use this overlay to check for product availability. width: 100%; #text-15297007 > * { color: #fff !important; /* Update text colour colour */ } }, Self-test for detection of SARSCoV2 antigen in individuals with suspected COVID19. Headquartered in San Diego, California, ACON Laboratories makes point-of-care medical diagnostics accessible to people around the world. align-self: center; Before you begin the test, it is important to read and follow the detailed instructions in the package insert. 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. Operating instructions for FlowFlex SARS-CoV-2 Antigen Rapid Test with prefilled extraction buffer tubes. 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. Toggle Nav. . Flowflex L031-118B5, COVID Rapid Antigen Home Test Kit, Each This test procedure overview does not replace the package insert. Blog. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. The Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. The Flowflex COVID-19 Rapid Antigen Test is the most accurate rapid antigen test on the market*. When the omicron variant emerged in late November 2021, scientists quickly responded to determine how PCR and rapid tests performed against this new variant.. Future shelf-life expiration date extensions will be communicated as they become available. Flowflex COVID-19 Home Test, FDA authorized Antigen test that requires only 1 test, results in 15 minutes, Nasal Swab. The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. 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. Hover to zoom. We also ask that you complete our questionnaire so our pharmacy team can check that this product is suitable for you to buy. } For use under an Emergency Use Authorization (EUA) only. 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). Next Day Delivery 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) Before CNET, she worked in local journalism covering public health issues, business and music. Easy and Affordable Detects New Omicron Strain MHRA Registered Nasal Only Test 98.8% Accuracy. -ms-grid-row-align: center; find out more. Target does not represent or warrant that the nutrition, ingredient, allergen and other product information on our Web or Mobile sites are accurate or complete, since this information comes from the product manufacturers. 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. Flowflex Lateral Flow Test SARS-CoV-2 Antigen Rapid - Box of 25 [COVID Test - Acon] 21.49. .cu-ticker .cu-ticker--container .button { Here's a quick overview of how it works: 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. } If you have an at-home COVID-19 Flowflex test that came in a dark blue box, don't use it, the US Food and Drug Administration said this month. But the same test cannot be "cannot be legally imported, distributed, or used" in the US and should be reported, according to the announcement. font-size: .82rem !important; Order by 10pm (subject to change during promotions), available 7 days a week for 4.95. 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% 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. 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.
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