Jiangsu Cowin Biotech(688426.SH): The nine-item respiratory pathogen nucleic acid detection kit (fluorescent PCR method) has obtained the medical device registration certificate.

date
16:41 04/03/2026
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GMT Eight
Kangwei Century (688426.SH) announced that its wholly-owned subsidiary Jiangsu Jianwei Diagnostic Technology Co., Ltd. (referred to as "Jianwei Diagnostic") has independently developed nine respiratory pathogen nucleic acid detection reagent kits (fluorescent PCR method) has received the Class III "Medical Device Registration Certificate (In vitro Diagnostic Reagents)" issued by the National Medical Products Administration.
Jiangsu Cowin Biotech (688426.SH) announced that its wholly-owned subsidiary Jiangsu Health Diagnosis Technology Co., Ltd. (referred to as "Health Diagnosis") has received the Class III "Medical Device Registration Certificate (In Vitro Diagnostic Reagent)" issued by the National Medical Products Administration for its independently developed nine-pathogen nucleic acid test kit for respiratory pathogens (fluorescent PCR method). According to the announcement, the respiratory pathogen detection product "Nine-Pathogen Nucleic Acid Test Kit for Respiratory Pathogens (Fluorescent PCR Method)" developed by Health Diagnosis this time is a fluorescent quantitative PCR method based on advanced lyophilization technology, used for in vitro qualitative detection of nucleic acids of influenza A virus (FluA), influenza B virus (FluB), respiratory syncytial virus (RSV), human rhinovirus (HRV), mycoplasma pneumoniae (MP), adenovirus (ADV), parainfluenza virus type I (PIV I), parainfluenza virus type II (PIV II) and parainfluenza virus type III (PIV III) in human throat swab samples.