Iindaba

I-Illumaxbio ifumene isaziso esivela kwi-CMDE (iZiko loVavanyo lweSixhobo sezoNyango) lweSichuan Medical Prouducts Administration ngoNovemba 11th, evuma ukuba i-Automatic Multiplex Immunoassay System ye-Illumaxbio inokuhlaziywa ngokuhambelana nenkqubo yokuphonononga okukhethekileyo kwi-in vitro diagnostics (IVD).Kuxelwa ukuba i-Illumaxbio yinkampani yokuqala ye-IVD kwiphondo laseSichuan ukungena kwinkqubo yokuphononongwa okukhethekileyo kwezixhobo zonyango kwi-2021. I-multiplex ye-automatic multiplex ye-Immunoassay System eqaliswe ngu-Illumaxbio, kunye noyilo olunobuchule kwiimfuno zeklinikhi, ukuphula iteknoloji. i-blockade yamacandelo amaninzi angundoqo, kwaye yonke ikhonkco izimeleyo kwaye iyalawuleka.

Ukufakwa kuluhlu lwezixhobo zonyango eziqalayo kuzwelonke kufuna kakhulu, ngexabiso lemvume le-5.2% kuphela ngo-2021. Iimfuno zezi zilandelayo:
·Unelungelo elilodwa lomenzi wechiza – Umfaki-sicelo unelungelo lelungelo elilodwa lomenzi wechiza okanye ilungelo lokusebenzisa ubuchwephesha obungundoqo bemveliso eTshayina ngokomthetho
·Ukwenziwa kwezinto ezintsha – owona mgaqo ungundoqo wokusebenza wemveliso linyathelo lokuqala lasekhaya ngumfaki-sicelo, kwaye ubuchwephesha bukwinqanaba lehlabathi elikhokelayo, elinexabiso lezonyango elicacileyo.
·Imveliso – Imveliso sele igqityiwe.Inkqubo yophando ilawulwa ngokwenene, kwaye idatha yophando iyalandeleka ngokupheleleyo.

Inkqubo yokuvunywa ekhethekileyo yindlela ekhawulezayo yezixhobo zonyango;Ulawulo lweeMveliso zezoNyango lweSizwe luya kunika kuqala ukuphononongwa kunye nokuvunywa kwisiseko sokuba imigangatho ayithotywanga kwaye iinkqubo azincitshiswa.Ngokwezibalo zoLawulo lweeMveliso zoNyango lweSizwe (i-NMPA), imveliso engena kwinkqubo yokuvunywa ekhethekileyo ifumana isatifikethi sokubhaliswa kwe-NMPA iintsuku ezingama-83 ngaphambili kunezinye iimveliso ezifanayo, ezinciphisa kakhulu umjikelo wesiqinisekiso kunye nokwandisa ukukhuphisana.Okukhona isatifikethi sobhaliso sifumana kwangethuba, elona thuba lingcono lokubamba isabelo semarike.