Pu'upu'u
Talu ai nei, Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-COV-2 lgM/IgG Antibody Rapid Test Kit ua fa'amaonia e le Brazilian National Health Supervision Bureau ma maua le tusipasi ANVISA.I le taimi lava e tasi, o le SARS-CoV-2 RT-PCR ma le IgM/IgG antibody rapid test kit o loʻo lisiina foʻi i luga o le lisi faʻatau fautuaina aloaia a Indonesia.
Ata 1 o Pasila ANVISA tusipasi
Pasila (ANVISA) tusipasi
ANVISA, ua taʻua o Agência Nacional de Vigilância Sanitária, o le faʻatonuga o masini faʻafomaʻi a Pasila.E mana'omia le resitalaina o se kamupani i le ANVISA, le National Health Supervision Agency, e fa'atau atu fa'aletulafono masini fa'afoma'i i Pasila.Ina ia faʻamaonia, o na masini faʻafomaʻi e ulufale atu i Pasila e tatau ona faʻamalieina manaʻoga a Pasila GMP faʻatasi ai ma tulaga faʻapitoa na faʻatulagaina e pulega a Pasila.I Pasila, IVD masini faʻafomaʻi ua faʻavasegaina i le Vasega I, II, III, ma le IV e tusa ai ma tulaga lamatia mai le maualalo i le maualuga.Mo Vasega I ma II oloa, o le Cadastro auala e faʻaaogaina, ae mo Vasega III ma IV oloa, o le Registro auala e faʻaaogaina.A maeʻa le resitalaina manuia, o le a tuʻuina atu se numera resitalaina e le ANVISA, ma o faʻamaumauga o le a tuʻuina atu i luga o faʻamaumauga o masini faʻafomaʻi a Pasila, o lenei numera ma ana faʻamatalaga resitalaina o le a faʻaalia i le DOU (Diário Oficial da União).
Ata 2 Le lisi o fa'atauga aloa'ia fautuaina a Initonesia
Ata 3 Laasaga Malosi®SARS-CoV-2 IgM/IgG Antibody Saosaoa Su'ega
Ata 4 Novel Coronavirus (SARS-CoV-2) Pusa PCR Taimi Moni Tele
Fa'aaliga:
O lenei pusa PCR sili ona maaleale, sauni e fa'aoga e maua i le lyophilized format (fa'agogo fa'a'aisa faiga) mo le teuina umi.O le pusa e mafai ona feaveaʻi ma teu i le vevela o le potu ma e mautu mo le tausaga e tasi.O paipa taʻitasi o premix o loʻo i ai mea uma e manaʻomia mo le faʻalauteleina o le PCR, e aofia ai Reverse-transcriptase, Taq polymerase, primers, probes, ma mea e fai ai le dNTPs.E naʻo le faʻaopoopoina o le 13ul vai faʻafefeteina ma le 5ul faʻapipiʻi RNA template, ona mafai lea ona faʻataʻitaʻiina ma faʻateleina i luga o meafaifaʻaili PCR.
SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (su'esu'eina mo kenera e tolu) sa fa'ailogaina muamua i le CE i Peretania, ma o lea ua talia ma fa'agasolo e EUA. o le FDA i Amerika.
Ole fa'ama'i lona lua ole COVID-19 i Europa ua sosolo talu ai nei.O le feagai ai ma le COVID-19, o le tulaga o loʻo faʻateleina le ogaoga.Nanjing Liming Bio-Products Co., Ltd. ua fa'atumauina ana matafaioi ma agafesootai.O le tu'ufa'atasia o tulaga lelei a le kamupani i le atina'eina o microbial diagnostic reagents, le SARS-CoV-2 IgM/IgG Antibody Rapid Test ma le Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (su'esu'eina mo kenera e tolu) (fa'amago-aisa. pauta) atiae e le kamupani ua matua viia e le maketi.
I le taimi nei, o le SARS-CoV-2 Antigen Rapid Test (Latex immunochromatography) ua faʻafouina fou ma atinaʻe, lea o le a tatalaina i se taimi lata mai.
Nanjing Liming Bio-Products Co., Ltd. o loʻo tuʻuina i taimi uma le tulaga lelei o le pusa suʻega i le mea muamua, ma o loʻo taulaʻi i le faʻalauteleina o le gafatia.O le kamupani o le a tuʻuina atu oloa ma auaunaga suʻega COVID-19 maualuga i faʻalapotopotoga faʻafomaʻi i le lalolagi atoa, ma saofagā i le puipuia ma le puleaina o faʻamaʻi o le lalolagi, ina ia fausia ai se faʻalapotopotoga faʻavaomalo o le lumanaʻi fefaʻasoaaʻi.
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Taimi meli: Iul-19-2020