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.
| Manufacturer | Test |
|---|---|
| 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) |
| Lifeassay | Test-it COVID-19 IgM/IgG Lateral Flow Assay |
| Phamatech | COVID19 IgG / IgM Rapid Test* |
| Promedical | COVID-19 Rapid Test |
| Saladax Biomedical | COVID-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 Testing | COVID-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)* |