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Modern Allergy Management LLC dba Direct Med Solutions LLC - 607769 - 06/17/2020
… reviewed your website at the Internet address https://covid.directmedsolutions.com/fingerstick on June 16, 2020. … kit that can be sent to KMBO Diagnostics, LLC for COVID-19 1 serology testing, specifically the “COVID-19 …
Mercola.com, LLC - 607133 - 02/18/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products are …
About Mineral - 613984 - 04/07/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
Medical Mikes, Inc. - 647603 - 01/10/2023
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products are …
Plum Dragon Herbs, Inc. - 05/08/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
Lusys Laboratories, Inc. - 625807 - 02/17/2022
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) The United States Food and Drug Administration (FDA) … that your firm is a medical device manufacturer of the COVID-19 IgG/IgM Antibody Test and a COVID-19 Viral Antigen …
Red Moon Herbs - 607640 - 11/18/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products …
CAMA Wellness Center/IodoRios Company, LLC - 613185 - 03/05/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [2] in people. Based on our review, this product is …
Industry Lab Diagnostic Partners - 609602 - 11/23/2020
… and send a nasopharangeal nasal swab sample to you for COVID-19 [1] testing (a “COVID-19 Testing Kit”). Based on our review, the COVID-19 …
EnMed MicroAnalytics, Inc. - 610131 - 01/25/2021
… individuals to send a blood or saliva sample to you for COVID-19 [1] serology or molecular testing, specifically the “COVID-19 BLOOD SPOT COLLECTION PACKET” and the “SARS-CoV-2 …
Lepu Medical Technology -Beijing- Co., Ltd. - 614908 - 07/29/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … Rapid Test (hereinafter collectively referred to as “COVID-19 Test Kits”) in the United States. Based on our …
OCLO LLC/OCLO Nanotechnology Science - 614310 - 05/27/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
MMSTabs.com - 609461 - 08/03/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
Lianhuaqingwencaps.com - 608667 - 07/06/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, this product is …
Ikcon Investments, Inc dba Ikcon Medical - 609791 - 03/25/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … your website, www.akcutestshop.com, offers the “Akcutest COVID-19 Antibody Test” (also referred to as the “Akcutest …
Prairie Dawn Herbs - 610877 - 10/07/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
Griffo Botanicals - 610434 - 10/07/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
Health Beauty Love - 608979 - 07/10/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, this product is …
Functional Remedies, LLC D/B/A Synchronicity Hemp Oil - 627208 - 03/28/2022
… Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products are …
Cureganics - 627288 - 03/28/2022
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products are …
Heaven’s Organic LLC - 627359 - 03/28/2022
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products are …
Center for New Medicine/Perfectly Healthy by Connealy MD - 605804 - 05/11/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products …
4nrx.md - 606115 - 05/13/2020
… and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet DATE: May … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 [1] in people. Based on our review, these products …
Heavenly Natural Products - 607470 - 12/02/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Based on our review, these products are …
Block Scientific - 609533 - 03/18/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … FDA has observed that your website offers the “QUIKPACII COVID-19 ANTIBODY TEST KIT” (hereinafter referred to as …