imikhiqizo

1. Ukushoda kwezinsiza zokuhlonza i-nucleic acid kuzoba inkinga yomhlaba wonke.

2. Amabhizinisi aseShayina IVD anekhono lokuya phesheya futhi ancintisane namabhizinisi asezingeni lomhlaba.

3, isiphithiphithi sokuhlola imakethe ye-reagent, isenzo esisemthethweni sokulawula izidakamizwa!

Amabhizinisi amaningi e-IVD athole iqoqo lokuqala lesitifiketi sangaphandle semikhiqizo yawo emisha ye-corona

Kuze kube manje, i-State Administration of Food and Drug Administration igunyaze amakhithi okuxilonga angaphandle komzimba angama-20 esimweni esiphuthumayo, okuhlanganisa ama-reagents okuthola i-nucleic acid angu-12 kanye nama-reagents angu-8 okuthola i-antibody.
Ngokombiko we-West China Securities Research Report, umhlaba usebenzisa amakhithi okuhlola ama-nucleic acid angu-500,000 kuya ku-700,000 nsuku zonke.Ukushoda kwamakhithi okuhlola i-nucleic acid kuzoba inkinga yomhlaba wonke, kanti isidingo samakhithi asebenza kahle kakhulu enziwe eChina kulindeleke ukuthi sihlale siphezulu.

Imininingwane yombiko wocwaningo ikhombisa ukuthi okungenani amazwe angama-26 athumele ama-oda wokuphakela eChina, kwa-odelwe amakhithi angaphezu kwezigidi eziyi-15."Ukushoda okubalulekile kwezinsizakusebenza zokuthola i-coronavirus kanye nemishini yokuzivikela YOMUNTU kusalokhu kungaxazululeki," kusho isitatimende se-AMA ngoLwesibili.

Muva nje, inani lemikhiqizo emisha ye-IVD yebhizinisi ngesitifiketi sokuqala sangaphandle emakethe.Phakathi kwezinkampani ezisohlwini, okungenani izinkampani ezisohlwini eziyi-9, okuhlanganisa iMeikang Biotechnology, Peoson Biotechnology, Cape Biotechnology, Anke Biotechnology, Daan Genomics, Wanfu Biotechnology, Mike Biotechnology kanye neHangzhou Realytech, zithi imikhiqizo yazo isithole isitifiketi se-EU CE.

AusDiagnostics inc., Roche Diagnostics Inc., Vivacheck Inc., Zhijiang Group LTD., CTK Group LTD.(TGA) kanye neHollogier Group Inc. (TGA) ngoMgqibelo, Mashi 22, ngokusho kwe-Australian Drug Administration (TGA).I-Hangzhou Otai, i-Vivacheck ne-Shanghai Zhijiang amabhizinisi asekhaya e-IVD.

E-United States, ngokwewebhusayithi esemthethweni ye-THE FDA, ikhithi ye-RT-PCR ye-fluorescent yesikhathi sangempela ekhiqizwe yi-BGI ukuze kutholwe i-SARS-2019-NCOV ivunyelwe yi-FDA futhi ingafakwa ngokusemthethweni ekuvimbeleni ubhubhane. kanye nokulawula e-United States.Lona umkhiqizo wokuqala waseShayina odlulise isigunyazo esiphuthumayo se-FDA.
Eqinisweni, amabhizinisi aseChinese IVD anamandla okuya phesheya futhi ancintisane namabhizinisi asezingeni lomhlaba.

I-Hangzhou Realytech isiphumelele isitifiketi se-FDA.Izinga lokutholwa kwe-Coronavirus inoveli liphezulu.Sicela ukhululeke ukuxhumana nathi uma udingathenga i-reagent ebona ngokushesha i-coronavirus ngamanani amakhulu.


Isikhathi sokuthumela: Jul-15-2020