Shanghai Kehua Bio-Engineering Secures Regulatory Approvals for Two New Diagnostic Kits

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Shanghai Kehua Bio-Engineering Co., Ltd. (SZSE: 002022) has announced that it, along with its controlled subsidiary Suzhou Tianlong Biotechnology Co., Ltd., has received medical device registration certificates for in vitro diagnostic reagents from China's National Medical Products Administration.

The newly certified products include a Chlamydia trachomatis nucleic acid detection kit (PCR-fluorescence method) and a Parainfluenza virus nucleic acid detection kit (fluorescence PCR method).

These registrations mark a significant expansion of the company's diagnostic product portfolio, allowing Shanghai Kehua Bio-Engineering to offer enhanced testing solutions for infectious diseases in clinical settings.

The approvals underscore the company's commitment to advancing molecular diagnostics and addressing growing public health needs for accurate and reliable pathogen detection.

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