Muva nje, i-StrongStep® SARS-CoV-2 Antigen Rapid Test (Professional Edition) evela e-Nanjing Liming Bio-products Co., Ltd. ithole isitifiketi se-Singapore HSA, i-Malaysia (MDA) enconyiwe, futhi ise-UK Umnyango Wezempilo kanye I-Human Services (DHSC) ihlole ngokuzimela futhi yathola ukunconywa.
Ngaphambi kwalokhu, i-StrongStep® SARS-CoV-2 ikhithi yokuthola i-antigen evela e-Nanjing Liming Bio-products Co., Ltd. ithole ngokulandelana isitifiketi se-EU CE, i-China National Institutes for Food and Drug Control (NIFDC) yokuqinisekisa ukubhaliswa kokubhaliswa, yangena eRockefeller. Isisekelo sohlu olunconyiwe, isitifiketi se-German Federal Agency for Medicines and Medical Devices (BfArM), , isitifiketi sase-Guatemala, isitifiketi se-FDA yase-Indonesia, isitifiketi soMnyango Wezempilo wase-Italy, isitifiketi se-FDA sase-Philippines, isitifiketi se-Singapore HSA, isitifiketi sase-Ecuador, isitifiketi saseBrazil (ANVISA), isitifiketi sase-Chile , isitifiketi sase-Argentina, isitifiketi se-Dominica, isitifiketi sase-Guatemala nezinye izitifiketi.Njengamanje, iNingizimu Afrika, i-India, i-EUL ye-WHO, i-EUA ye-FDA, i-European whitelist nezinye izicelo zokuthola izitifiketi ziyaqhubeka.
Umthombo wesithombe: Kunconywe uMnyango Wezempilo wase-Malaysian
Isithombe: Isitifiketi se-HSA saseSingapore
(Umthombo wesithombe: Iwebhusayithi esemthethweni ye-DHSC yoMnyango Wezempilo kanye Nezinsizakalo Zabantu waseBrithani)
Ngo-2020, uMnyango Wezempilo Nezinkonzo Zabantu e-United Kingdom uzoqinisekisa ngokuqinile izikhungo zokuxilonga ngokushesha ze-COVID-19 ezingena ezweni ukuze uqinisekise ukuthi zinembe ngokwanele futhi zithembekile.Kunemikhiqizo engu-120 ebambe iqhaza ohlelweni lokuqinisekisa, okuyimikhiqizo engu-19 kuphela ephumelele ukuqinisekiswa.Ngemva kwezinyanga eziyisi-6 zokuqinisekisa okuphindaphindiwe nokuqinisekisa, izibonelo ezinhle ezingu-200 kanye nezibonelo ezimbi eziyi-1,000 zafakazela ngokugcwele ukusebenza okuphezulu kwe-reagent ye-Nanjing Liming Bio-products Co., Ltd. yokuhlonza ngokushesha i-COVID-19.
(Umthombo wesithombe: Iwebhusayithi ye-Federal Agency for Medicines and Medical Devices (BfArM) esemthethweni yaseJalimane)
I-ID Yokuhlola Isitifiketi Esisemthethweni: AT593/21
I-StrongStep® SARS-CoV-2 Antigen Rapid Test version yokuzihlola (isigaba sokuzihlola) igunyazwe uMnyango Wezempilo wase-Italy
Umthombo: Iwebhusayithi esemthethweni yoMnyango Wezempilo wase-Italy (Ministero della Salute)
I-StrongStep® SARS-CoV-2 Antigen Rapid Test yanconywa futhi yanconywa abasebenzisi base-Italy
Ukuhlolwa kwe-antigen ye-SARS-CoV-2 kuyashesha, kunembile, kulula ukusebenza, futhi kudinga amathuluzi aphansi kanye nabasebenzi.Ifaneleka kakhulu uphenyo olusheshayo lwamacala asolwayo okutheleleka ngegciwane elisha lomqhele, ikakhulukazi ekuxilongeni ngokushesha kokuqubuka okugxilile.Ingasetshenziswa njengendlela yokuqala yokuzivikela ekulawuleni ubhubhane, isetshenziswe ekutholeni izifo kusenesikhathi, ukusiza ukuvimbela nokulawula ubhubhane, nokulawula ukusabalala kwegciwane.
I-COVID-19 izoba sesimweni sobhubhane lwesikhathi eside esikhathini esizayo, futhi isidingo sokuhlolwa sizokhula kakhulu.Ngezimo ezihlukene zohlelo lokusebenza, iNanjing Liming Bio-products Co., Ltd. ithuthukise izinhlobonhlobo zokutholwa kwe-SARS-CoV-2, "SARS-CoV-2 nucleic acid discover + SARS-CoV-2 antigen discover + SARS-CoV- 2 ukutholwa kwe-antibody + i-SARS-CoV-2 / A no-B yokuhlolwa okuphindwe kathathu kwe-antigen + i-SARS-CoV-2 / A kanye nokuhlolwa okuphindwe kathathu kwe-nucleic acid ye-nucleic + ukuhlolwa komndeni wakwa-SARS-CoV-2 "Isixazululo sesimo esigcwele sihlangabezana nezidingo yokutholwa nokuvimbela kuwo wonke amazinga ezimakethe zomhlaba.Siza ngokugcwele ukuvimbela nokulawula ubhubhane lomhlaba wonke lwe-COVID-19 kanye nokuvimbela nokulawulwa kwezifo zokuphefumula ezinjengomkhuhlane.
Isikhathi sokuthumela: Jun-23-2021
