Biotech & Health

FDA Says 28 COVID-19 Testing Kits Should No Longer Be Used

MBS Staff

The U.S. Food and Drug Administration announced that 28 COVID-19 testing kits will no longer be on its “notification list” under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

The agency with its main campus in Silver Spring says its keeping up with its commitment to transparency.

"Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests," said FDA Commissioner Stephen M. Hahn, M.D. "We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public."

Here’s the list of testing kits that were removed from the FDA’s “notification list”,

Manufacturer

Test

Status

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