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SHA:603658

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Asia

Autobio Diagnostics' Units Get Registration Certificates for Four Devices

Autobio Diagnostics' (SHA:603658) units, Zhengzhou Antu Bioengineering and Zhengzhou Biaoyuan Biotechnology, received medical device registration certificates from China's National Medical Products Administration for four devices, according to a Tuesday disclosure on the Shanghai bourse.The devices are the genetic sequencer SikunRapidGS 480, the mycoplasma pneumoniae antigen detection kit, the Epstein-Barr virus capsid antigen IgG antibody detection kit, which both use the magnetic particle chemiluminescence method, and the Epstein-Barr virus antibody control II.

SHA:603658
Asia

Autobio Diagnostics Cancels Medical Device Licenses

Autobio Diagnostics (SHA:603658) secondary Zhengzhou Biaoyuan voluntarily canceled its medical device operating license and Class Two medical device operating filing certificate.The move is part of an internal business restructuring and resource integration strategy, according to a Tuesday aftermarket filing with the Shanghai bourse.Shares of the medical technology company closed 3% lower Wednesday.

SHA:603658
Asia

Autobio Diagnostics' Unit Renews Medical Device Manufacturing License

Autobio Diagnostics' (SHA:603658) unit, Autobio Laboratory Instruments (Zhengzhou), renewed its medical device manufacturing license after changing its manufacturing scope, according to a Shanghai bourse filing on Thursday.The new manufacturing scope included in vitro diagnostic software, immunoassay equipment, microbiological analysis kits, and other similar equipment.The Henan Medical Products Administration issued the renewed license, which is valid until May 20, 2031.

SHA:603658
Asia

Autobio Diagnostics Secures Two Medical Device Certificates

Autobio Diagnostics (SHA:603658) and subsidiary Autobio Instrument obtained two new medical device registration certificates from Henan's medical products regulator, according to a Wednesday filing with the Shanghai bourse.The products include a multi-parameter test data management software for clinical lab data processing, and an interleukin 12p70 detection kit using magnetic particle chemiluminescence for quantitative testing in serum and plasma.Both certificates are valid for five years.Shares of the medical technology company closed 1% lower Thursday.

SHA:603658

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