Abstract
Muva nje, i-Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-COV-2 lgM/IgG Antibody Rapid Test Kit iqinisekiswe yi-Brazilian National Health Supervision Bureau futhi yathola isitifiketi se-ANVISA.Ngasikhathi sinye, i-SARS-CoV-2 RT-PCR kanye nekhithi yokuhlola esheshayo ye-IgM/IgG antibody nazo zifakwe ohlwini lokuthenga olunconyiwe olusemthethweni lwase-Indonesia.
Isithombe 1 isitifiketi se-Brazil ANVISA
Isitifiketi saseBrazil (ANVISA).
I-ANVISA, eyaziwa nge-Agência Nacional de Vigilância Sanitária, isilawuli semishini yezokwelapha yase-Brazil.Kudingeka ukuthi inkampani ibhaliswe ne-ANVISA, I-National Health Supervision Agency, ukuze ithengise imishini yezokwelapha ngokusemthethweni e-Brazil.Ukuze zigunyazwe, lezo zisetshenziswa zezokwelapha ezingena e-Brazil kufanele zihlangabezane nezimfuneko ze-Brazilian GMP kanye namazinga athile abekwe iziphathimandla zase-Brazilian.E-Brazil, izinsiza zezokwelapha ze-IVD zihlukaniswa zibe Ikilasi I, II, III, kanye ne-IV ngokwezinga lengozi ukusuka kokuphansi ukuya phezulu.Emikhiqizweni ye-Class I kanye ne-II, indlela ye-Cadastro iyamukelwa, kuyilapho emikhiqizweni ye-Class III ne-IV, indlela ye-Registro isetshenziswa.Ngemva kokubhaliswa ngempumelelo, inombolo yokubhalisa izokhishwa i-ANVISA, futhi idatha izolayishwa kusizindalwazi sedivayisi yezokwelapha yaseBrazil, le nombolo kanye nolwazi oluhambisanayo lokubhalisa kuzovela ku-DOU (Diário Oficial da União).
Isithombe 2 Uhlu olusemthethweni olunconyiwe lokuthenga lwase-Indonesia
Isithombe 3 Isinyathelo Esiqinile®Ukuhlolwa Okusheshayo kwe-SARS-CoV-2 IgM/IgG Antibody
Isithombe 4 se-Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR kit
Qaphela:
Le kit ye-PCR ezwela kakhulu, elungele ukusetshenziswa itholakala ngefomethi ye-lyophilized (inqubo yokumisa iqhwa) ukuze igcinwe isikhathi eside.Ikhithi ingathuthwa futhi igcinwe ekamelweni lokushisa futhi izinzile unyaka owodwa.Ishubhu ngayinye ye-premix iqukethe wonke ama-reagents adingekayo ukuze kukhuliswe i-PCR, okuhlanganisa i-Reverse-transcriptase, i-Taq polymerase, ama-primers, ama-probe, nama-dNTPs substrates.Idinga kuphela ukungeza amanzi acwecwe angu-13ul kanye nesifanekiso se-RNA esikhishwe ngu-5ul, bese singasetshenziswa futhi sikhuliswe kumathuluzi e-PCR.
I-SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (ukutholwa kwezakhi zofuzo ezintathu) ibikade imakwe njenge-CE e-UK, futhi manje yamukelwa futhi yenziwa yi-EUA. we-FDA eMelika.
Ukugqashuka kwesibili kwe-COVID-19 eYurophu kusabalele muva nje.Sibhekene ne-COVID-19, isimo siya ngokuya siba sibi kakhulu.I-Nanjing Liming Bio-Products Co., Ltd. isithathe umthwalo wayo oyimfanelo nowomphakathi.Ukuhlanganisa izinzuzo zenkampani ekuthuthukisweni kwama-microbial diagnostic reagents, i-SARS-CoV-2 IgM/IgG Antibody Rapid Test kanye neNovel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (ukutholwa kwezakhi zofuzo ezintathu) (iqhwa powder) eyakhiwe yinkampani iye yanconywa kakhulu yimakethe.
Khonamanjalo, i-SARS-CoV-2 Antigen Rapid Test (Latex immunochromatography) isanda kuthuthukiswa futhi yathuthukiswa, ezokhishwa maduze nje.
I-Nanjing Liming Bio-Products Co., Ltd. ibilokhu ibeka ikhwalithi yekhithi yokuhlola kuqala, futhi igxile ekwandiseni umthamo.Inkampani izohlinzeka ngemikhiqizo namasevisi okuhlola i-COVID-19 ekhwalithi ephezulu ezikhungweni zezokwelapha emhlabeni wonke, futhi ifake isandla ekunqandeni nasekulawuleni ubhubhane lomhlaba wonke, ukuze kwakhiwe umphakathi womhlaba wonke wekusasa okwabelwana ngalo.
Cindezela Okude~Skena futhi Usilandele
I-imeyili:sales@limingbio.com
Iwebhusayithi: https://limingbio.com
Isikhathi sokuthumela: Jul-19-2020
