Abstract
Kutshanje, iNanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-COV-2 lgM/IgG Antibody Rapid Test Kit iye yaqinisekiswa yiBrazilian National Health Supervision Bureau kwaye yafumana isatifikethi se-ANVISA.Kwangaxeshanye, i-SARS-CoV-2 RT-PCR kunye ne-IgM/IgG antibody ikiti yovavanyo olukhawulezayo nazo zidweliswe kuluhlu olusemthethweni olucetyiswayo lokuthengwa kwempahla yase-Indonesia.
Umfanekiso woku-1 wesatifikethi seBrazil ANVISA
Isiqinisekiso saseBrazil (ANVISA).
I-ANVISA, eyaziwa ngokuba yi-Agência Nacional de Vigilância Sanitária, ngumlawuli wesixhobo sonyango saseBrazil.Kuyimfuneko ukuba inkampani ibhaliswe kunye ne-ANVISA, i-Arhente yoLawulo lwezeMpilo yeSizwe, ukuthengisa izixhobo zonyango ngokusemthethweni eBrazil.Ukuze uqinisekiswe, ezo zixhobo zonyango zingena eBrazil kufuneka zihlangabezane neemfuno zeBrazilian GMP kunye nemigangatho ethile ebekwe ngabasemagunyeni baseBrazil.EBrazil, izixhobo zonyango ze-IVD zihlelwa kwiKlasi I, II, III, kunye ne-IV ngokwezinga lomngcipheko ukusuka phantsi ukuya phezulu.Kwiimveliso zeKlasi I kunye ne-II, indlela yeCadastro iyamkelwa, ngelixa i-Class III kunye ne-IV yeemveliso, indlela yeRegistro isetyenziswa.Emva kokubhaliswa okuyimpumelelo, inombolo yobhaliso iya kukhutshwa ngu-ANVISA, kwaye idatha iya kufakwa kwi-database yesixhobo sezonyango saseBrazil, le nombolo kunye nolwazi oluhambelanayo lokubhalisa luya kubonakala kwi-DOU (Diário Oficial da União).
Umfanekiso wesi-2 Uluhlu lokuthengwa kwempahla olusemthethweni lwase-Indonesia
Umfanekiso we-3 Inyathelo eliqinileyo®Uvavanyo oluKhawulezayo lwe-SARS-CoV-2 IgM/IgG Antibody
Umfanekiso wesi-4 weNoveli yeCoronavirus (SARS-CoV-2) Multiplex yeXesha lokwenyani PCR kit
Phawula:
Le khithi yePCR enovakalelo kakhulu, elungele ukusetyenziswa iyafumaneka kwifomati ye-lyophilized (inkqubo yokumisa umkhenkce) yokugcina ixesha elide.Ikiti inokuthuthwa kwaye igcinwe kwiqondo lokushisa kwaye izinzile unyaka omnye.Ityhubhu nganye ye-premix iqulethe zonke ii-reagents ezifunekayo kwi-PCR amplification, kubandakanywa i-Reverse-transcriptase, i-Taq polymerase, i-primers, i-probes, kunye ne-dNTPs substrates.Ifuna kuphela ukongeza i-13ul yamanzi e-distilled kunye ne-5ul ekhutshwe i-template ye-RNA, ngoko inokuqhuba kwaye ikhuliswe kwizixhobo ze-PCR.
I-SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (ukuchongwa kweegenes ezintathu) ibikhe yaphawulwa e-UK, kwaye ngoku yamkelwe kwaye isenziwa yi-EUA. ye-FDA eMelika.
Uqhambuko lwesibini lwe-COVID-19 eYurophu lunwenwele mva nje.Ukujongana ne-COVID-19, imeko iya isiba mandundu.I-Nanjing Liming Bio-Products Co., Ltd. ithathele ingqalelo uxanduva lwayo kunye nentlalontle.Ukudibanisa izinto eziluncedo zenkampani kuphuhliso lwe-microbial diagnostic reagents, i-SARS-CoV-2 IgM/IgG Antibody Rapid Test kunye neNoveli yeCoronavirus (SARS-CoV-2) Multiplex yeXesha lokwenyani PCR Kit (ukufunyanwa kofuzo ezintathu) (umkhenkce-womisiwe. powder) ephuhliswe yinkampani iye yanconywa kakhulu yimarike.
Ngeli xesha, uvavanyo olukhawulezileyo lwe-SARS-CoV-2 Antigen Rapid (Latex immunochromatography) lusanda kuphuculwa kwaye lwaphuhliswa, oluya kukhutshwa kungekudala emva koko.
I-Nanjing Liming Bio-Products Co., Ltd. isoloko ibeka umgangatho wekiti yokuvavanya kwindawo yokuqala, kwaye igxininise ekwandiseni umthamo.Inkampani iya kubonelela ngeemveliso zovavanyo olukumgangatho ophezulu we-COVID-19 kunye neenkonzo kumaziko ezonyango kwihlabathi liphela, kwaye ifake isandla kuthintelo nolawulo lobhubhane wehlabathi, ukuze kwakhiwe uluntu lwehlabathi lwekamva ekwabelwana ngalo.
Cinezela ixesha elide ~ Skena kwaye Usilandele
I-imeyile:sales@limingbio.com
Iwebhusayithi: https://limingbio.com
Ixesha lokuposa: Jul-19-2020
