Novel Coronavirus Testing Products of 8 IVD Companies Get EU

From July to September, domestic in vitro diagnostic companies Assure Tech. (Hangzhou) Co., Ltd., Jiangsu CoWin Biosciences Co.,Ltd., Xiamen Biotime Biotechnology Co.,Ltd.，Xiamen Zeesan Biotech Co.,Ltd.， ZhuHai Sinochips Bioscience Co., Ltd. ，Snibe， Beijing  Wantai  Biological Pharmacy Enterprise Co., Ltd.， Jiangsu Well Biotech Co., Ltd. have successively obtained Emergency Use Authorization(EUA) issued by US Food and Drug Administration (FDA) .

As of September 23, 2020, FDA has urgently authorized 255 novel coronavirus testing products at home and abroad. According to CACLP statistics, there are more than 19 domestic in vitro diagnostic companies.

List of domestic products that have been awarded FDA EUA from July to September 2020

(In reverse chronological order)

Jiangsu Well Biotech Co., Ltd.
 

Approved date: September 23, 2020

Device：Orawell IgM/IgG Rapid Test

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
 

Approved date:  September 9, 2020

Device：WANTAI SARS-CoV-2 RT-PCR Kit

Approved date:  August 5, 2020

Device：WANTAI SARS-CoV-2 Ab ELISA

Approved date:  July 10, 2020

Device：WANTAI SARS-CoV-2 Ab Rapid Test 

Snibe
 

Approved date:  September 14, 2020

Device：MAGLUMI 2019-nCoV IgM/IgG

ZhuHai Sinochips Bioscience Co., Ltd. 
 

Approved date:  August 17, 2020

Device：COVID-19 Nucleic Acid RT-PCR Test Kit

Xiamen Zeesan Biotech Co.,Ltd.

Approved date:  July 31, 2020

Device：SARS-CoV-2 Test Kit (Real-time PCR)

Xiamen Biotime Biotechnology Co.,Ltd.  

Approved date:  July 24, 2020

Device：BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test

Jiangsu CoWin Biosciences Co.,Ltd.
 

Approved date:  July 24, 2020

Device：Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

Assure Tech. (Hangzhou) Co., Ltd.

Approved date:  July 6, 2020

Device：Assure COVID-19 IgG/IgM Rapid Test Device