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25th May 2020  Product update: rapidmicrobiology staff writer

FDA Clampdown on Non-Compliant COVID-19 Serology Test Manufacturers 


The US FDA has told serology test kit manufacturers that they can no longer distribute serology tests in the US unless they fulfil obligations under the 'Policy for Coronavirus Disease-2019'. The FDA, as of the 25th of May, has removed 29 test kits from its list of commercial Manufacturers distributing serology test kits, for not submitting an FDA-EUA application within a reasonable time-frame and/or not addressing invalidity issues in their tests. 

The FDA also now has specific performance thresholds that testing products must meet.

The list of kits that have yet to comply with the FDA's instructions will be added to the FDA's 'What Tests Should No Longer Be Distributed for COVID-19?

Here is the current list of tests no longer allowed to be distributed in the US.

  • Artron BioResearch/Artron Laboratories, COVID-19 IgM/IgG Antibody Test
  • BestNovo (Jiangsu) Medical Technology, BestNovo COVID-19 IgM/IgG Antibody Rapid Test kit
  • Biobase Biodustry (Shandong), SARS-CoV-2 IgM/IgG Antibody Test kit (colloidal gold)
  • BioMedomics, COVID-19 IgM-IgG rapid test
  • Bioscience (Chongqing) Diagnostic Technology, Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
  • Bioscience (Chongqing) Diagnostic Technology, Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
  • Bioscience (Tianjin) Diagnostic Technology, Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
  • Bioscience (Tianjin) Diagnostic Technology, Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
  • Boson Biotech (Distributed by Pure Genetic Medical), Rapid 2019-nCoV IgG/IgM Combo Test Card
  • Changchun Wancheng Bio-Electron, COVID-19 IgG/IgM Antibody Rapid Test kit (colloidal gold immunochromatography)
  • Diazyme Laboratories, Diazyme SARS-CoV-2 Antibody Rapid Test
  • Genlantis Diagnostics, CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test
  • Hangzhou Clongene Biotech, COMBRA COVID-19 IgM/IgG Rapid Test Cassette
  • Hangzhou Testsea Biotechnology, One Step SARS-CoV2 (COVID-19) IgG/IgM Test
  • Hunan RunKun Pharmaceutical, SARS-CoV-2 lgM/lgG Test kit (colloidal gold)
  • IMMY, clarus SARS-CoV-2 Total Antibody EIA
  • Jiangsu Eubo Biotechnology, EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
  • Lifeassay, Test-it COVID-19 IgM/IgG Lateral Flow Assay
  • Phamatech, COVID-19 IgG / IgM Rapid Test
  • Promedical, COVID-19 Rapid Test
  • Saladax Biomedical, COVID-19 IgG/IgM Rapid Antibody Test
  • Shanghai Eugene Biotech, SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
  • Shenzen Landwind Medical, COVID-19 IgG/IgM Rapid Test
  • Vita Testing, COVID-19 IgM/IgG Antibody Rapid Test Kit
  • Zhengzhou Fortune Bioscience, COVID-19 Antibody Rapid Test Kit (colloidal gold immunochromatography method)
  • Zhengzhou Fortune Bioscience, COVID-19 IgM Antibody Rapid Test kit
  • Zhengzhou Fortune Bioscience, COVID-19 IgG Antibody Rapid Test kit
  • Zhongshan Bio-Tech, SARS-CoV-2 IgM/IgG (GICA)

    

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Date Published: 25th May 2020

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.