I-Genobio iyahola futhi ——Izinga lemboni le-“Bacterial Endotoxin Test Kit” likhishwa ngokusemthethweni

Isiqalo esisha sezinga lemboni

Ilandela i-YY/T 1729-2020 “Ikhithi yokunquma i-glucan ye-YY/T 1-3)-β-D, YY/T 1793-2021 “Bacterial Endotoxin Determination Kit” eyakhiwe yi-Genobio izokhishwa ngo-2021 NgoSepthemba 9, yavunywa. yi-State Drug Administration futhi yakhululwa ngokusemthethweni.Izinga lizosetshenziswa ngokusemthethweni ngoMashi 1, 2023.

Ukulungiswa kwezinga le-“Bacterial Endotoxin Test Kit” kwahlelwa yiNational Medical Clinical Laboratory kanye ne-In Vitro Diagnostic System Standardization Technical Committee (TC136), futhi yethulwa ngokusemthethweni ngo-April 2019. Nge-Genobio Pharmaceutical Co., Ltd. umdidiyeli wokuqala, ohlanganiswe neBeijing Medical Device Inspection Institute, Beijing Medical Device Evaluation Center, Shanghai Clinical Testing Center, Beijing Jinshanchuan Technology Development Co., Ltd. (Izinkampani ezingaphansi eziphethwe ngokuphelele) kanye namanye amayunithi amaningi abhalwe ngokuhlanganyela futhi akhiwe.

Njengenkampani ehamba phambili embonini yokuhlola ngokushesha isikhunta/amagciwane, iGenobio izibophezele ekuthuthukiseni amazinga omkhiqizo okuqhubekayo.Iminyaka engaphezu kwengu-20, besiqondiswa isikhundla esihamba phambili embonini kanye nemakethe emisiwe njengomhlahlandlela wethu, siqhubekela phambili nezikhathi, silwela ukuphelela, futhi siphishekela ukwenza kahle ngokuqhubekayo.Ukumenyezelwa kwaleli zinga kungamisa ngempumelelo ikhwalithi yemikhiqizo embonini futhi kuthuthukise isithunzi semboni yokuhlola i-endotoxin yebhaktheriya kuwo wonke umkhakha wokuxilongwa kwe-in vitro.

Ikhithi Yokubona I-Endotoxin Yegciwane (indlela ye-Chromogenic)

I-Genobio izoqhubeka nokusebenzisa ngenkuthalo umsebenzi ojwayelekile wokukhangisa nokuqaliswa, futhi ikhuthaze ukuthuthukiswa kwekhwalithi yomkhiqizo wemboni.Ngesikhathi esifanayo, izisebenzi zezobuchwepheshe zizohlelwa ukuba ziqhube ukukhangisa okujwayelekile kanye nokuqeqeshwa kokuqaliswa kwabasebenzisi bezokwelapha kanye nelabhorethri ezibhedlela ezinkulu, futhi "bathumele izindinganiso endlini".

Ngokuzayo, i-Genobio izoqhubeka nokusebenzisa izinzuzo zobuchwepheshe zomholi wemboni, ithathe isinyathelo sokubamba iqhaza ekwakhiweni kwamanye amazinga omkhiqizo ahlobene, inikele ngamandla ayo enqubweni yokumisa inqubo yemboni yokuxilonga ye-in vitro, futhi iphelezele ukuthuthukiswa okuphephile imboni yezokwelapha yezwe lami!