FDA publica lista de pruebas de COVID-19 que no deben ser manufacturadas ni distribuidas

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Anhui Deepblue Medical Technology Co., Ltd. COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) Removed – Should Not Be Distributed Artron BioResearch Inc./ Artron Laboratories Inc. COVID-19 IgM/IgG Antibody Test Removed – Should Not Be Distributed* BestNovo (Jiangsu) Medical Technology Co., Ltd. BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit Removed – Should Not Be Distributed Biobase Biodustry (Shandong) Co., Ltd. SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) Removed – Should Not Be Distributed BioMedomics, Inc. COVID-19 IgM-IgG rapid test Removed – Should Not Be Distributed* Bioscience(Chongqing) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody Removed – Should Not Be Distributed Bioscience(Chongqing) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody Removed – Should Not Be Distributed Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM Antibody Removed – Should Not Be Distributed Bioscience(Tianjin) Diagnostic Technology Co., Ltd. Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG Antibody Removed – Should Not Be Distributed Boson Biotech Ltd. Co (Distributed by Pure Genetic Medical Ltd.) Rapid 2019-nCoV IgG/IgM Combo Test Card Removed – Should Not Be Distributed Changchun Wancheng Bio-Electron Co., Ltd. COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) Removed – Should Not Be Distributed Diazyme Laboratories, Inc. Diazyme SARS-CoV-2 Antibody Rapid Test Removed – Should Not Be Distributed* Genlantis Diagnostics, Inc. CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test Removed – Should Not Be Distributed* Hangzhou Clongene Biotech Co., Ltd. COMBRA COVID-19 IgM/IgG Rapid Test Cassette Removed – Should Not Be Distributed Hangzhou Testsea Biotechnology Co., Ltd. One Step SARS-CoV2(COVID-19) IgG/IgM Test Removed – Should Not Be Distributed* Hunan RunKun Pharmaceutical Co., Ltd. SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold) Removed – Should Not Be Distributed* IMMY, Inc. clarus SARS-CoV-2 Total Antibody EIA Removed – Should Not Be Distributed* Jiangsu Eubo Biotechnology Co., Ltd. EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) Removed – Should Not Be Distributed Lifeassay Test-it COVID-19 IgM/IgG Lateral Flow Assay Removed – Should Not Be Distributed Phamatech COVID19 IgG / IgM Rapid Test Removed – Should Not Be Distributed* Promedical COVID-19 Rapid Test Removed – Should Not Be Distributed Saladax Biomedical COVID-19 IgG/IgM Rapid Antibody Test Removed – Should Not Be Distributed* Shanghai Eugene Biotech Co., Ltd. SARS-CoV2 (COVID-19) IgG/IgM Rapid Test Removed – Should Not Be Distributed Shenzen Landwind Medical Co., Ltd. COVID-19 IgG/IgM Rapid Test Removed – Should Not Be Distributed* VITA Testing COVID-19 IgM/IgG Antibody Rapid Test Kit Removed – Should Not Be Distributed Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) Removed – Should Not Be Distributed Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgM Antibody Rapid Test Kit Removed – Should Not Be Distributed Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgG Antibody Rapid Test Kit Removed – Should Not Be Distributed Zhongshan Bio-Tech Co Ltd. SARS-CoV-2 IgM/IgG (GICA) Removed – Should Not Be Distributed*





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