Kutshanje, iStrongStep® SARS-CoV-2 Antigen Rapid Test (uHlelo lobuNgcali) oluvela eNanjing Liming Bio-products Co., Ltd. ifumene iSitifiketi se-HSA saseSingapore, iMalaysia (MDA) eluluhlu olucetyiswayo, kwaye ise-UK. Iinkonzo zoluntu (DHSC) zavavanya ngokuzimeleyo kwaye zafumana ukunconywa.
Ngaphambi koku, i-StrongStep® SARS-CoV-2 ikiti yokubona i-antigen evela e-Nanjing Liming Bio-products Co., Ltd. ifumene ngokulandelelana isatifikethi se-EU CE, iZiko leSizwe leSizwe loLawulo lokuTya kunye noLawulo lweZiyobisi (NIFDC) lobhaliso lokuqinisekisa ubhaliso, lingene eRockefeller. Uluhlu olucetyisiweyo lweSiseko, i-Arhente yaseJamani ye-Arhente yamaYeza kunye neZixhobo zoNyango (i-BfArM) isiqinisekiso, isiqinisekiso saseGuatemala, isatifikethi se-FDA sase-Indonesia, isiqinisekiso soMphathiswa wezeMpilo wase-Italiya, isiqinisekiso se-FDA sePhilippines, isatifikethi se-HSA saseSingapore, isatifikethi se-Ecuador, isiqinisekiso saseBrazil (ANVISA), isiqinisekiso saseChile , isatifikethi saseArgentina, isatifikethi seDominica, isatifikethi saseGuatemala kunye nezinye iziqinisekiso.Okwangoku, uMzantsi Afrika, i-Indiya, i-EUL ye-WHO, i-EUA ye-FDA, i-European whitelist kunye nezinye izicelo zoqinisekiso ziyaqhubeka.
Umthombo womfanekiso: Kucetyiswa nguMphathiswa wezeMpilo waseMalaysia
Umfanekiso: Isatifikethi saseSingapore seHSA
(Umthombo womfanekiso: Iwebhusayithi esemthethweni ye-DHSC yeSebe lezeMpilo laseBritane kunye neeNkonzo zoLuntu)
Ngo-2020, iSebe lezeMpilo kunye neeNkonzo zoLuntu e-United Kingdom liza kuqinisekisa ngokungqongqo iiarhente zokuxilonga ezikhawulezayo ze-COVID-19 ezingena kweli lizwe ukuqinisekisa ukuba zichanekile ngokwaneleyo kwaye zithembekile.Kukho iimveliso ze-120 ezithatha inxaxheba kwinkqubo yokuqinisekisa, apho kuphela iimveliso ze-19 ziphumelele ukuqinisekiswa.Emva kweenyanga ezi-6 zoqinisekiso oluphindaphindiweyo kunye nokuqinisekiswa, iisampuli ezingama-200 ezichanekileyo kunye ne-1,000 leesampulu ezingalunganga zibonakalise ngokupheleleyo ukusebenza okuphezulu kweNanjing Liming Bio-products Co., Ltd.
(Umthombo womfanekiso: I-website ye-Arhente yaseJamani ye-Federal for Medicines and Medical Devices (BfArM))
Uvavanyo lwesiqinisekiso esisemthethweni se-ID: AT593/21
I-StrongStep® SARS-CoV-2 Antigen Rapid Test self-test version (icandelo lokuzivavanya) yamkelwe liSebe lezeMpilo lase-Italiya.
Umthombo: Iwebhusayithi esemthethweni yeSebe lezeMpilo lase-Italiya (uMphathiswa della Salute)
IStrongStep® SARS-CoV-2 Antigen Rapid Test yanconywa kwaye yacetyiswa ngabasebenzisi base-Italiya
Uvavanyo lwe-antigen ye-SARS-CoV-2 luyakhawuleza, luchanekile, kulula ukulusebenza, kwaye lufuna izixhobo eziphantsi kunye nabasebenzi.Ilunge kakhulu kuphando olukhawulezileyo lwamatyala arhanelwayo osulelo olukhulu lwentsholongwane yesithsaba esitsha, ngakumbi ukuxilongwa ngokukhawuleza koqhambuko olugxile.Ingasetyenziswa njengomgca wokuqala wokukhusela ubhubhane, isetyenziswe ekubhaqweni kosulelo kwangethuba, ukuncedisa ekuthinteleni nasekulawuleni ubhubhane, nokulawula ukusasazeka kwentsholongwane.
I-COVID-19 iya kuba kwimeko yesifo sexesha elide kwixesha elizayo, kwaye imfuno yovavanyo iya kunyuka kakhulu.Ngeemeko ezahlukeneyo zesicelo, iNanjing Liming Bio-products Co., Ltd. iphuhlise iindidi zokuchongwa kwe-SARS-CoV-2 reagents, "SARS-CoV-2 nucleic acid ubhaqo + SARS-CoV-2 antigen ubhaqo + SARS-CoV- Uvavanyo olu-2 lwe-antibody + i-SARS-CoV-2 / A kunye ne-B yovavanyo olukhawulezayo lwe-antigen kathathu + i-SARS-CoV-2 / A kunye novavanyo oluphindwe kathathu lwe-nucleic acid + i-SARS-CoV-2 yosapho lokuzihlola "Isisombululo esigcweleyo siyahlangabezana neemfuno yokufunyanwa kunye nokuthintela kuwo onke amanqanaba kwimarike yehlabathi.Ukuncedisa ngokupheleleyo kuthintelo kunye nolawulo lwendyikityha ye-COVID-19 kunye nothintelo kunye nolawulo lwezifo zokuphefumla ezinjengomkhuhlane.
Ixesha lokuposa: Jun-23-2021
