iimveliso

1. Ukunqongophala kwezixhobo zokubona i-nucleic acid kuya kuba yingxaki yehlabathi.

2. Amashishini e-IVD aseTshayina anamandla okuya phesheya kwaye akhuphisane namashishini akumgangatho wehlabathi.

I-3, i-chaos ye-reagent yokuvavanya imarike, inyathelo elisemthethweni lokulawula iziyobisi!

Uninzi lwamashishini e-IVD afumene ibhetshi yokuqala yesatifikethi sangaphandle kwiimveliso zabo ezintsha ze-corona

Ukuza kuthi ga ngoku, i-State Administration of Food and Drug Administration ivume iikiti ze-20 zokuxilonga ngaphandle komzimba kwimeko engxamisekileyo, kubandakanywa ne-12 ye-nucleic acid yokufumanisa i-reagents kunye ne-8 antibody reagents.
Ngokutsho kwe-West China Securities Research Report, ihlabathi lidla i-500,000 ukuya kwi-700,000 yeekhithi zokuvavanya i-nucleic acid yonke imihla. Ukunqongophala kwezixhobo zokuvavanya i-nucleic acid iya kuba yingxaki yehlabathi, ngelixa imfuno yeekiti eziphezulu ezenziwe e-China kulindeleke ukuba zihlale ziphezulu.

Idatha yengxelo yophando ibonisa ukuba ubuncinci amazwe angama-26 angenise iiodolo zobonelelo eTshayina, ngaphezulu kwe-15 yezigidi zeekiti eziyalelweyo. "Ukunqongophala okubalulekileyo kwezixhobo zokufumanisa i-coronavirus entsha kunye nezixhobo zokukhusela zomntu zihlala zingasonjululwanga," utshilo i-AMA kwingxelo ngoLwesibini.

Kutshanje, inani lemveliso ye-IVD yeshishini elitsha ngesatifikethi sokuqala sangaphandle kwimarike. Phakathi kweenkampani ezidwelisiweyo, ubuncinane iinkampani ezi-9 ezidweliswe, kuquka i-Meikang Biotechnology, i-Peoson Biotechnology, i-Cape Biotechnology, i-Anke Biotechnology, i-Daan Genomics, i-Wanfu Biotechnology, i-Mike Biotechnology kunye ne-Hangzhou Realytech, bathi iimveliso zabo zifumene isatifikethi se-EU CE.

AusDiagnostics inc., Roche Diagnostics Inc., Vivacheck Inc., Zhijiang Group LTD., CTK Group LTD. (TGA) kunye neHologier Group Inc. (TGA) ngoMgqibelo, ngo-Matshi 22, ngokutsho kwe-Australian Drug Administration (TGA). I-Hangzhou Otai, iVivacheck kunye neShanghai Zhijiang ngamashishini asekhaya e-IVD.

EUnited States, ngokwewebhusayithi esemthethweni ye-FDA, ikhithi ye-fluorescent ye-RT-PCR yexesha lokwenyani eveliswe yi-BGI yokuchongwa kwe-SARS-2019-NCOV yamkelwe yi-FDA kwaye inokufakwa ngokusemthethweni kuthintelo lobhubhane. kunye nolawulo eUnited States. Le yimveliso yokuqala yaseTshayina egqithise ugunyaziso olungxamisekileyo lwe-FDA.
Ngapha koko, amashishini aseTshayina e-IVD anamandla okuya phesheya kwaye akhuphisane namashishini akumgangatho wehlabathi.

I-Hangzhou Realytech iphumelele isiqinisekiso se-FDA. Izinga lokufunyanwa kweCoronavirus inoveli liphezulu. Nceda uzive ukhululekile ukuqhagamshelana nathi ukuba ufuna njaloThenga i-coronavirus ekhawulezayo yokufumanisa i-reagent ngobuninzi.


Ixesha lokuposa: Jul-15-2020