IQela le-Era Biology “Umgangatho weShishini weFungus (1-3)-β-D-Glucan Test” Yamkelwa kwaye Yakhululwa.

I-YY/T 1729-2020 "I-Fungus (1-3)-β-D-Glucan Test" eyenziwe yi-Era Biology yamkelwa yi-NMPA ngoJulayi 9, 2020 kwaye yakhululwa ngokusemthethweni.Umgangatho uya kuphunyezwa ngokusesikweni ngomhla woku-1 kuJuni, ngo-2021.

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Ukulungiswa kwalo mgangatho waququzelelwa yiNational Medical Clinical Laboratory kunye ne-In Vitro Diagnostic System Standardization Committee (TC136) , kwaye yasungulwa ngokusemthethweni ngo-Aprili 2017. I-Beijing Gold Mountainriver Tech Development Co., Ltd., i-subsidiary ye-Era Ibhayoloji, njengomyili wokuqala, isebenzisana neBeijing Medical Device Inspection Institute, iBeijing Medical Device Technology Evaluation Centre, iNational Health Commission Testing Centre, kunye neGenobio Pharmaceutical Co., Ltd. (i-subsidiary ephethwe ngokupheleleyo ye-Era Biology), iqulunqwe ngokudibeneyo kwaye yaqulunqa umgangatho.Njengomgangatho wokuqala weshishini kwintsimi yokubonwa ngokukhawuleza kwefungus, ekhokelwa lishishini, umgangatho uchaza ukuchaneka, umgca, umda ongenanto, umda wokufumanisa, kunye nokuphindaphinda, umahluko webhotile ukuya kwi-batch, i-batch-batch umahluko. , uhlalutyo oluthile, iimfuno zokuzinza kunye neendlela zokuvavanya, njl., Uvavanyo lwefungus (1-3) -β-D-glucan.Lo mgangatho uyasebenza kwiikiti zokumisela ubungakanani befungal (1-3) -β-D glucan kwi-serum yabantu kunye neplasma nge-spectrophotometry esekelwe kumgaqo we-chromogenic method.

Njengenkampani ekhokelayo kushishino lokuhlola umngundo olukhawulezileyo lwasekhaya, i-Era Biology ayigcwalisi nje umsantsa wasekhaya kwi-swoop enye, kodwa ikwaphuhlise imveliso yokuqala yoxilongo olukhawulezayo lwezifo zokungunda ezihlaselayo, kwaye izibophelele ekuphuculeni okuqhubekayo kwemigangatho yemveliso.Ngaphezulu kweminyaka engama-20, sibekwe njengenkokeli yoshishino, sikhokelwa kukumiselwa komgangatho weemarike, sihambela phambili rhoqo namaxesha, sizabalazela ukugqibelela, kwaye siqhubeka nokusukela ukugqwesa.Ukuqulunqwa kwalo mgangatho kubonise amandla e-brand ehamba phambili kuvavanyo lwefungus kwishishini.Ukubhengezwa kwalo mgangatho kunokulinganisa ngokufanelekileyo umgangatho weemveliso kwishishini kunye nokuphucula isidima somzi mveliso wovavanyo lomngundo kuyo yonke inkalo ye-in vitro diagnostics.

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Ixesha lokuposa: Mar-31-2021