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NMPA-Registered Molecular Diagnostic Kit (Type III)

China

Class III medical device molecular diagnostic kit registered with China's NMPA regulatory authority. Meets stringent requirements for clinical in vitro diagnostic applications.

Manufactured by

China

YZY Medical is a high-tech enterprise specializing in personalized molecular diagnostics for cardiovascular and oncology applications. The company has developed 160+ genetic diagnostic products and multiple IVD devices, with 14 molecular diagnostic kits holding NMPA Class III registration. Technical platforms include ARMS qPCR, multiplex qPCR, mass spectrometry, FISH, and circulating tumor cell detection. The company operates a 2,000 sqm R&D center and 3,200 sqm GMP production facility with ISO13485:2016 and CE certifications.

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