Sansure Biotech’s SARS-CoV-2 L452R/E484K/K417N Variant Diagnostic Kit received marketing authorization approval from Ministère des Solidarités et de la Santé (Ministry of Solidarity and Health) the other day. This is Sansure Biotech’s fifth SARS-CoV-2 detection product that has received marketing authorization approval from Ministère des Solidarités et de la Santé. The Omicron variant of SARS-CoV-2 is now spreading rapidly and rampantly […]
Sansure Biotech’s HPV DNA Diagnostic Kit (HPV 13+2) was approved by the China NMPA on January 6, with reference to the medical device approval released on the NMPA’s official website. This is another blockbuster product from Sansure Biotech in promoting the global elimination of cervical cancer. In 2020, WHO launched a global strategy to accelerate the elimination of cervical cancer, […]
On December 21, a SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) developed by Sansure Biotech was included in EU Health Security Committee (HSC) Common List. Hence, the product has been accredited by yet another international certification body, following its CE certification and inclusion in the common lists of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) […]
The kit developed by Sansure Biotech for nucleic acid detection of SARS-CoV-2, and influenza A & B virus (PCR-Fluorescence Probing) was approved by the National Medical Products Administration (NMPA) for marketing on December 17. It has also received CE mark and is expected to provide critical support for global COVID-19 prevention and control. According to WHO estimates, influenza causes 3 to 5 […]
On December 8, Sansure Biotech’s SARS-CoV-2 Neutralizing Antibodies Test (Colloidal Gold) and SARS-CoV-2 S-RBD Antibodies Test (Colloidal Gold) passed CE certification and received the certificate. This is the first batch of antibody products in the company’s immune product line to receive international authoritative registration certificate following the antigen detection kits receiving CE certification, which further enriches the company’s immune product […]