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Synthgene Medical Technology's COVID-19 Antigen Self Test Kit was certified by the UK CTDA

Industry news | 27 December, 2022 | CACLP


Recently, Nanjing Synthgene Medical Technology Co., Ltd. added good news. The independently developed "COVID-19 antigen detection kit SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)" by Synthgene Medical Technology was approved by the UK 5-year CTDA certification, which is another international authoritative certification of this product after dozens of certifications such as China's NMPA and EU CE self-test. The successful approval of this product means that the Synthgene New Corona Antigen Self Test Kit can be sold in the UK, further serving the needs of normal epidemic prevention of COVID-19 in the UK.



Coronavirus Test Device Approvals (CTDA for short) is a regulation issued by the British government for COVID-19 Test Reagents. Relevant enterprises need to register and pass the CTDA approval procedure before they can sell COVID-19 testing products in the UK. The CTDA registration certificate in the UK has a high gold content. At present, there are not many enterprises obtaining CTDA product registration certificates in China. Synthgene Medical Technology can obtain the CTDA certification, which once again proves that Synthgene Medical Technology COVID-19 Antigen Self Test Kit has excellent quality and reliable performance.



Previously, this antigen detection reagent has obtained China NMPA certification, EU CE self-test certification, Thailand FDA certification and Peru DIGEMID certification, and has been included in the HSC common list. In addition, this reagent has also passed the performance verification of German PEI; At the same time, it has also been recognized by many European countries, such as the French Agency for Drug Safety (ANSM) COVID-19 antigen white list, the German Federal Drug and Medical Device Agency (BfArM) white list, the Portuguese Drug Administration white list, and the Belgian Federal Agency for Drugs and Health Products (FAMHP) white list, and has been widely recognized by the global market.

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