The first in China! Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit of Sansure Biotech Certified by UK CTDA
2022-05-06 yang, rongchang

The first in China! Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit of Sansure Biotech Certified by UK CTDA


Sansure Biotech May 06,2022

Recently, the Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) developed by Sansure Biotech has got UK CTDA approval, and before that, MHRA registration was completed for this product, meaning that the kits could be marketed in the UK legally. This is the first COVID-19 molecular testing reagent approved in China after the UK government implemented the new registration rules for COVID-19 testing reagents, and it is also another international authoritative certification after this product obtained more than 40 international certifications such as EU CE and US FDA.

The marketing of COVID-19 testing reagents in the UK requires CTDA examination and MHRA registration certification. Due to the high requirements of CTDA examination on product performance, there are not many COVID-19 products that can be legally sold in the UK at present. The clinical performance and analytical performance of the Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) of Sansure Biotech meet the high requirements of CTDA, and the product has been further validated and fully recognized by CTDA.

Currently, there is still a long way to go in the prevention and control of global epidemic. With its product certified globally, Sansure Biotech will continue to contribute to the prevention and control of the global epidemic.

 

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