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Avazo-Healthcare, LLC - 610282 - 11/30/2020
… CBD Market Web 605 Louis Dr Ste 02 Warminster, PA 18974 COVID Test Shop 605 Louis Dr Ste 502 Warminster, PA 18974 … products. The FDA has observed that your websites offers COVID-19 1 test kit products and CBD products for sale in the …
Medakit Ltd - 607603 - 06/10/2020
… a serology test for at-home testing, specifically the “COVID-19 Rapid Test Kit” (aka “COVID-19 IgM/IgG Rapid Test” and “Covid-19 Fast Test Kit”). …
Kaleido Biosciences, Inc. - 616026 - 08/26/2021
… Parallel Group Study to Assess the Natural History of COVID-19 1 and Effects of KB109 in Addition to Supportive Self Care … Health in Non-hospitalized Patients with Mild-to-Moderate COVID-19” Protocol K032-120: “An Exploratory, Open Label, …
Amplicon Land, LLC - 607975 - 06/07/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … your website, www.amplicondist.com, offers the “QuikPacII COVID-19 IgG/IgM Test” (also referred to as “COVID-19 …
CoreMedica Laboratories, Inc. - 608757 - 07/24/2020
… instructed individuals to send a blood sample to you for COVID-19 [1] serology testing, specifically the “COVID-19 (SARS-CoV-2) ANTIBODY SCREENING KIT Specimen …
Alive By Nature, Inc. - 607435 - 05/06/2020
… 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 …
My Natural Treatment - 624734 - 02/22/2022
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … products can mitigate, prevent, treat, diagnose, or cure COVID-19 2 in people. Based on our review, these claims cause …
Trinity Natural Health & Pain Management, Inc. - 614007 - 04/13/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … products. The FDA has observed that your website offers “COVID-19 Formula” for sale in the United States and that this …
Anytime COVID Test LLC - 611366 - 04/13/2021
… rcement-and-criminal-investigations/warning-letters/anytime-covid-test-llc-611366-04132021 … WARNING LETTER Date: April … Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and …
Baltimore Beauty Security Square Mall - 614182 - 05/04/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) The United States Food and Drug Administration (FDA) has … observed that your business offers for sale the GenBody COVID-19 Ag test (hereinafter “GenBody antigen test”) and the …
For Our Vets LLC dba Patriot Supreme - 611043 - 10/16/2020
… 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 …
Sensory Cloud, Inc - 628897 - 04/06/2022
… 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 an …
21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics - 607654 - 07/21/2020
… Adulterated 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. There is currently a global outbreak of …
Biopolygen Corp. - 613137 - 07/09/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … has observed that your website offers the “COVIGEN AG-1 Covid-19 Self Detection Kit,” the “COVIDEX AB-1 Covid-19 Self …
AkivaMed Inc. - 609211 - 07/23/2020
… 8, 2020. The FDA has observed that your website offers a “COVID-19 Antibody Rapid Test Kit” for sale in the United States … mitigation, prevention, treatment, diagnosis, or cure of COVID-19 1 in people, and thus, it is a device under section …
Iodine Products Inc - 628296 - 03/25/2022
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … your website offers Liquid Mask Spray Anti-Viral and The COVID-Killer for sale in the United States and that these …
Greenway Herbal Products LLC - 627042 - 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 …
ChromaDex - 607692 - 11/17/2020
… 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 [2] in people. Based on our review, these products …
Fair Price Labs, Inc. - 607832 - 07/24/2020
… of your own Home” and send “Overnight back to Lab” for COVID-19 1 serology testing, specifically the “covid-19 home test kit” (also referred to as the ““COVID-19 …
Alternative Health Distribution LLC d/b/a CannaAid - 641241 - 11/01/2022
… 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 …
Beauty & Spa Concepts, DBA Beenefits - 613072 - 05/24/2021
… 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 1 in people. Based on our review, this product is an …
Pomegranate Consulting, LLC, Pomegranate Consulting, Ltd. dba Glorious One-Pot Meals - 608068 - 08/18/2020
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … 2020. The FDA has observed that your website offers a “COVID-19 test package” for sale in the United States directly …
FluxxLab LLC - 637158 - 08/04/2022
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … The FDA has observed that your website offers the Covid-19 Immune Support Tincture and the CBDA+CBD Oil …
Pacific Center of Health/Pacific Center of Health & Acupuncture - 614526 - 06/22/2021
… Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and … Cough, Lung Formula Wet Cough, Colloidal Silver and Post COVID-19 Recovery products for sale in the United States and …
Rowpar Pharmaceuticals - 611759 - 12/18/2020
… 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 …