NewsCoronavirus

Actions

FDA cracking down on anti-body tests

COVID-19 antibody test plays big role in learning more about the disease
Posted at 6:11 AM, May 22, 2020
and last updated 2020-05-22 06:11:03-04

The FDA is cracking down on anti-body testing and requiring companies to file paperwork showing their tests work.

More than two dozen companies with tests already on the marker failed to submit their applications on time, and some have already pulled their product.

The FDA says the manufacturers in the following list have been removed from its notification list.

ManufacturerTest
Artron BioResearch Inc./ Artron Laboratories Inc.COVID-19 IgM/IgG Antibody Test*
BestNovo (Jiangsu) Medical Technology Co., Ltd.BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit
Biobase Biodustry (Shandong) Co., Ltd.SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)
BioMedomics, Inc.COVID-19 IgM-IgG rapid test*
Bioscience(Chongqing) Diagnostic Technology Co., Ltd.Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody
Bioscience(Chongqing) Diagnostic Technology Co., Ltd.Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM Antibody
Bioscience(Tianjin) Diagnostic Technology Co., Ltd.Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG Antibody
Boson Biotech Ltd. Co (Distributed by Pure Genetic Medical Ltd.)Rapid 2019-nCoV IgG/IgM Combo Test Card
Changchun Wancheng Bio-Electron Co., Ltd.COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)
Diazyme Laboratories, Inc.Diazyme SARS-CoV-2 Antibody Rapid Test*
Genlantis Diagnostics, Inc.CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test*
Hangzhou Clongene Biotech Co., Ltd.COMBRA COVID-19 IgM/IgG Rapid Test Cassette
Hangzhou Testsea Biotechnology Co., Ltd.One Step SARS-CoV2(COVID-19) IgG/IgM Test*
Hunan RunKun Pharmaceutical Co., Ltd.SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold)*
IMMY, Inc.clarus SARS-CoV-2 Total Antibody EIA*
Jiangsu Eubo Biotechnology Co., Ltd.EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)
LifeassayTest-it COVID-19 IgM/IgG Lateral Flow Assay
PhamatechCOVID19 IgG / IgM Rapid Test*
PromedicalCOVID-19 Rapid Test
Saladax BiomedicalCOVID-19 IgG/IgM Rapid Antibody Test*
Shanghai Eugene Biotech Co., Ltd.SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
Shenzen Landwind Medical Co., Ltd.COVID-19 IgG/IgM Rapid Test*
VITA TestingCOVID-19 IgM/IgG Antibody Rapid Test Kit
Zhengzhou Fortune Bioscience Co., Ltd.COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method)
Zhengzhou Fortune Bioscience Co., Ltd.COVID-19 IgM Antibody Rapid Test Kit
Zhengzhou Fortune Bioscience Co., Ltd.COVID-19 IgG Antibody Rapid Test Kit
Zhongshan Bio-Tech Co Ltd.SARS-CoV-2 IgM/IgG (GICA)*

Click here for more information.