LimingBio ua maua le resitalaina ANVISA i Pasila ma le tusi resitala i Sigapoa ma Initonesia

LimingBio has obtained the ANVISA registration in Brazil

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 ai 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.I le taimi nei, Liming Bio StrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, na faʻamaonia e le Singapore Health Sciences Authority (HSA), ma maua ai le tusi faamaonia HSA.

LimingBio has obtained the ANVISA registration in Brazil1

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).

LimingBio has obtained the ANVISA registration in Brazil2
LimingBio has obtained the ANVISA registration in Brazil3

Ata 2 Sigapoa Health Sciences Authority (HSA) tusi faamaonia

LimingBio has obtained the ANVISA registration in Brazil4
LimingBio has obtained the ANVISA registration in Brazil6

Ata 3 Le lisi o fa'atauga aloa'ia fautuaina a Initonesia

LimingBio has obtained the ANVISA registration certificate in Brazil and entered the official procurement list in Indonesia6

Ata 4 Laasaga Malosi®SARS-CoV-2 IgM/IgG Antibody Saosaoa Su'ega

LimingBio has obtained the ANVISA registration in Brazil7

Ata 5 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.

Le faigata ole felauaiga o filifili malulu ole Novel Coronavirus nucleic acid detection reagent

Pe a felauaiga reagents su'esu'ega nucleic acid masani i le mamao, o le (-20±5) ℃ malulu filifili filifili ma felauaiga e manaomia ina ia mautinoa le bioactive o le enzyme i le reagents tumau malosi.Ina ia mautinoa o le vevela e oʻo i le tulaga masani, e manaʻomia le tele o kilokalama o le aisa mago mo pusa taʻitasi o suʻega suʻega nucleic acid e tusa lava pe itiiti ifo i le 50g, ae e mafai ona tumau mo le lua pe tolu aso.I le va'aiga o faiga fa'apisinisi, o le mamafa moni o reagents na tu'uina atu e le au gaosi oloa e itiiti ifo i le 10% (pe itiiti ifo nai lo lenei tau) o le koneteina.O le tele o le mamafa e sau mai le aisa mago, pusa aisa ma pusa foam, o lea o le tau o felauaiga e matua maualuga lava.

Ia Mati 2020, na amata ai ona sosolo le COVID-19 i se fua tele i fafo, ma o le manaʻoga mo Novel Coronavirus nucleic acid detection reagent na matua faʻateleina.E ui i le maualuga o le tau o le auina atu i fafo o reagents i le filifili malulu, o le tele o tagata gaosi oloa e mafai lava ona talia ona o le tele ma le maualuga o tupe maua.

Ae ui i lea, faʻatasi ai ma le faʻaleleia atili o faiga faʻavae a le atunuʻu mo oloa faʻatau atu i fafo, faʻapea foʻi ma le faʻaleleia o le pulega a le atunuʻu i luga o le tafe o tagata ma logistics, o loʻo i ai le faʻaopoopoga ma le le mautonu i le taimi o felauaiga o reagents, lea na mafua ai faʻafitauli iloga o oloa na mafua ai. e ala i le felauaiga.Fa'aumi taimi felauaiga (taimi felauaiga e tusa ma le afa masina e masani lava) e ta'ita'i atu ai i le fa'aletonu o oloa pe a o'o atu le oloa i le kalani.O lenei mea ua fa'alavelave ai le tele o pisinisi fa'atau atu i fafo atu o le nucleic acid reagents.

Lyophilized technology mo PCR reagent na fesoasoani i le felauaiga o Novel Coronavirus nucleic acid detection reagent i le lalolagi atoa

O le lyophilized PCR reagents e mafai ona feaveaʻi ma teuina i le vevela o le potu, lea e le gata ina faʻaitiitia ai le tau o felauaiga, ae faʻapea foi ona aloese mai faʻafitauli lelei e mafua mai i felauaiga.O le mea lea, lyophilizing le reagent o le auala sili lea e foia ai le faafitauli o le auina atu i fafo felauaiga.

Lyophilization e aofia ai le fa'aisa aisa o se vaifofo i se tulaga mautu, ona fa'asusu lea ma tu'ueseese le ausa vai i lalo ole tulaga gaogao.O lo'o tumau pea le solu mago i totonu o le atigipusa ma le tu'ufa'atasiga tutusa ma le gaioiga.Pe a faʻatusatusa i vai faʻafefe masani, o le lyophilized Novel Coronavirus nucleic acid detection reagent na gaosia e Liming Bio e iai uiga nei:

Malosi le malosi o le vevela: e mafai ona tu i le 56 ℃ mo le 60 aso, ma o le morphology ma le faatinoga o le reagent e tumau pea e le suia.
O le teuina o le vevela masani ma le felauaiga: leai se manaʻoga mo filifili malulu, leai se manaʻoga e teu i le maualalo o le vevela aʻo leʻi tatalaina, faʻamatuʻu atoa le avanoa malulu.
Sauni-e faʻaoga: lyophilizing o vaega uma, e le manaʻomia mo le faʻatulagaina o faiga, aloese mai le leiloa o vaega e maualuga le viscosity pei ole enzyme.
Fuafuaga tele i totonu o le faagaau e tasi: o le sini e iloa ai e aofia ai le tala fou o le coronavirus ORF1ab gene, N gene, S gene e aloese ai mai le siama genovariation.Ina ia faʻaitiitia le leaga sese, o le tagata RNase P gene e faʻaaogaina e avea ma pulea i totonu, ina ia faʻamalieina le manaʻoga faʻapitoa mo faʻataʻitaʻiga lelei.

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.

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.

Lomi umi~Scan and Follow Us
imeli:sales@limingbio.com
Upega tafaʻilagi: https://limingbio.com

LimingBio has obtained the ANVISA registration certificate in Brazil and entered the official procurement list in Indonesia9

Taimi meli: Iul-06-2020