Biopharma group Jiangsu Bioperfectus Technologies Co Ltd – based in the Taizhou Medical High Tech Zone, also known as the Gaogang district of Taizhou city, in East China's Jiangsu province – has been awarded key certifications.
It recently received a certification issued by the National Medical Products Administration and obtained important European Union certification, called the CE marking, for its Norovirus reagent.
The CE marking is an abbreviation of the French phrase Conformite Europeenne, which translates as European Conformity. It is a conformity mark used to monitor and regulate goods sold within the European Union.
The achievement is expected to strengthen the company's position in the field of infectious diarrhea disease detection.
The Norovirus reagent can detect a highly contagious pathogen that causes acute gastroenteritis.
The certifications are said to demonstrate the product's adherence to quality standards and its ability to provide reliable and accurate results.
Additionally, the company has developed a Norovirus nucleic acid detection kit that uses the fluorescent PCR method. This kit has also been granted a medical device registration certificate, indicating its compliance with regulatory requirements.
The launch of the Norovirus kit is understood to represent a significant advancement in the company's pathogen detection service capacity.
Furthermore, Jiangsu Bioperfectus Technologies Co Ltd has become the first company to offer in-vitro diagnostic services covering the detection of four common pathogens – norovirus, rotavirus, salmonella and shigella.
This accomplishment is widely said to underscore the company's commitment to providing comprehensive and accurate diagnostic solutions and cements its position as a leading player in the field of infectious disease diagnostics.