Kangwei Century's Mycoplasma Pneumoniae Detection Kit Receives Class III Medical Device Registration Certificate

Product / Tech
โดย 中国证券报·CN·Read original
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Jiangsu Jianwei Diagnostic Technology Co., Ltd., a wholly-owned subsidiary of Kangwei Century, has independently developed a Mycoplasma pneumoniae nucleic acid and drug-resistance mutation site detection kit using fluorescent PCR. The kit recently obtained a Class III Medical Device Registration Certificate for in vitro diagnostic reagents from the National Medical Products Administration, valid until August 16, 2031. The product is used for in vitro qualitative detection of Mycoplasma pneumoniae DNA and its antibiotic resistance mutation sites 23S rRNA 2063 A to G and 23S rRNA 2064 A to G in human throat swab samples. Using fluorescent PCR technology, it can simultaneously detect the Mycoplasma pneumoniae P1 gene nucleic acid and its macrolide antibiotic resistance mutation sites. A single sampling and a single test can confirm infection and provide drug resistance information at the same time, helping to avoid failure of empirical medication and improve treatment success rates. The product is compatible with mainstream fluorescent quantitative PCR platforms and is suitable for a wide range of settings, including fever clinics, respiratory departments, pediatrics, and primary healthcare institutions. As of the announcement date, this product is the company's fifth Class III registration certificate for respiratory disease detection, further enriching its product pipeline in the field of respiratory pathogen detection. It marks important progress in the company's integrated molecular diagnostic product layout of infection diagnosis plus drug resistance testing, and is expected to enhance the company's competitiveness in the molecular diagnostic market for respiratory infections.

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Kangwei Century's subsidiary obtained a Class III medical device registration for a new Mycoplasma pneumoniae detection kit, enhancing its product pipeline.

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