LimingBio yapeza kulembetsa kwa ANVISA ku Brazil ndi satifiketi yolembetsa ku Singapore ndi Indonesia

LimingBio has obtained the ANVISA registration in Brazil

Ndemanga
Posachedwapa, Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit yatsimikiziridwa ndi Brazilian National Health Supervision Bureau ndipo inalandira chiphaso cha ANVISA.Nthawi yomweyo, SARS-CoV-2 RT-PCR ndi IgM/IgG antibody test kit adalembedwanso pamndandanda wovomerezeka wovomerezeka waku Indonesia.Pakadali pano, Liming Bio StrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, idavomerezedwa ndi Singapore Health Sciences Authority (HSA), ndikupeza satifiketi ya HSA.

LimingBio has obtained the ANVISA registration in Brazil1

Chithunzi 1 chiphaso cha Brazil ANVISA

Satifiketi yaku Brazil (ANVISA).
ANVISA, yemwe amadziwika kuti Agência Nacional de Vigilância Sanitária, ndi wowongolera zida zamankhwala ku Brazil.Ndikofunikira kuti kampani ilembetse ndi ANVISA, National Health Supervision Agency, kuti igulitse zida zamankhwala movomerezeka ku Brazil.Kuti zitsimikizidwe, zida zamankhwala zomwe zimalowa ku Brazil ziyenera kukwaniritsa zofunikira za GMP yaku Brazil komanso miyezo yokhazikitsidwa ndi akuluakulu aku Brazil.Ku Brazil, zida zachipatala za IVD zimagawidwa m'magulu a I, II, III, ndi IV malinga ndi kuchuluka kwa chiwopsezo kuchokera kumunsi kupita kumtunda.Pazinthu za Class I ndi II, njira ya Cadastro imatengedwa, pomwe pazinthu za Class III ndi IV, njira ya Registro imagwiritsidwa ntchito.Pambuyo polembetsa bwino, nambala yolembetsa idzaperekedwa ndi ANVISA, ndipo deta idzatumizidwa ku database ya chipangizo chachipatala cha ku Brazil, nambala iyi ndi zolembera zogwirizana nazo zidzawonekera pa DOU (Diário Oficial da União).

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

Chithunzi 2 satifiketi ya Singapore Health Sciences Authority (HSA).

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

Chithunzi 3 Akuluakulu adalimbikitsa mndandanda wazogula waku Indonesia

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

Chithunzi 4 ChamphamvuStep®SARS-CoV-2 IgM/IgG Antibody Rapid Test

LimingBio has obtained the ANVISA registration in Brazil7

Chithunzi 5 Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR kit

Zindikirani:
Zida za PCR zomverera kwambiri, zokonzeka kugwiritsa ntchito zimapezeka mumtundu wa lyophilized (njira yowumitsa zowuma) kuti zisungidwe kwa nthawi yayitali.Chombocho chikhoza kunyamulidwa ndikusungidwa kutentha kwa chipinda ndipo chimakhala chokhazikika kwa chaka chimodzi.Chubu chilichonse cha premix chimakhala ndi ma reagents ofunikira pakukulitsa kwa PCR, kuphatikiza Reverse-transcriptase, Taq polymerase, primers, probes, ndi dNTPs substrates.Zimangofunika kuwonjezera madzi osungunuka a 13ul ndi template ya 5ul yotulutsidwa ya RNA, ndiye kuti imatha kuthamanga ndikukulitsidwa pazida za PCR.

Kuvuta kwamayendedwe ozizira a Novel Coronavirus nucleic acid discovery reagent

Pamene ma reagents odziwika bwino a nucleic acid amanyamulidwa patali, (-20 ± 5) ℃ kusungirako kuzizira kwa unyolo ndi zoyendera zimafunika kuwonetsetsa kuti ma enzyme mu reagents amakhalabe achangu.Kuonetsetsa kuti kutentha kumafika pamlingo, ma kilogalamu angapo a ayezi wouma amafunikira pabokosi lililonse la nucleic acid kuyesa reagent ngakhale zosakwana 50g, koma zimatha masiku awiri kapena atatu okha.Potengera machitidwe amakampani, kulemera kwenikweni kwa ma reagents operekedwa ndi opanga ndi ochepera 10% (kapena ocheperako kuposa mtengo uwu) wa chidebecho.Zolemera zambiri zimachokera ku ayezi wouma, mapaketi a ayezi ndi mabokosi a thovu, kotero kuti mtengo wamayendedwe ndi wokwera kwambiri.

Mu Marichi 2020, COVID-19 idayamba kufalikira kumayiko ena, ndipo kufunikira kwa Novel Coronavirus nucleic acid kuzindikira reagent kudakula kwambiri.Ngakhale mtengo wamtengo wapatali wotumizira ma reagents mu unyolo wozizira, opanga ambiri amatha kuvomerezabe chifukwa cha kuchuluka kwakukulu komanso phindu lalikulu.

Komabe, ndi kusintha kwa ndondomeko za dziko zogulitsa katundu zotsutsana ndi mliri, komanso kukweza ulamuliro wa dziko pa kayendetsedwe ka anthu ndi kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka anthu. ndi mayendedwe.Nthawi yowonjezereka yoyendera (nthawi yoyendera pafupifupi theka la mwezi ndiyofala kwambiri) imayambitsa kulephera kwazinthu pafupipafupi pomwe mankhwalawo afika kwa kasitomala.Izi zasokoneza mabizinesi ambiri ogulitsa ma nucleic acid.

Tekinoloje ya Lyophilized ya PCR reagent idathandizira mayendedwe a Novel Coronavirus nucleic acid kuzindikira reagent padziko lonse lapansi.

The lyophilized PCR reagents akhoza kunyamulidwa ndi kusungidwa kutentha kwa firiji, zomwe sizingangochepetsa mtengo wa zoyendetsa, komanso kupewa mavuto omwe amadza chifukwa cha kayendetsedwe ka kayendetsedwe kake.Choncho, lyophilizing ndi reagent ndiyo njira yabwino yothetsera vuto la kutumiza kunja.

Lyophilization imaphatikizapo kuziziritsa njira kukhala yolimba, ndiyeno sublimate ndikulekanitsa nthunzi wamadzi pansi pa vacuum.The solute zouma amakhala mu chidebe ndi zikuchokera chimodzimodzi ndi ntchito.Poyerekeza ndi ma reagents ochiritsira amadzimadzi, gawo lonse la lyophilized Novel Coronavirus nucleic acid kuzindikira reagent yopangidwa ndi Liming Bio ili ndi izi:

Kukhazikika kwamphamvu kwambiri kwa kutentha: kumatha ndi chithandizo cha 56 ℃ kwa masiku 60, ndipo mawonekedwe ndi magwiridwe antchito a reagent amakhalabe osasinthika.
Kusungirako kutentha kwanthawi zonse ndi zoyendera: palibe chifukwa cha unyolo wozizira, osafunikira kusunga kutentha pang'ono musanamasule, kumasula kwathunthu malo osungira ozizira.
Okonzeka ntchito: lyophilizing onse zigawo zikuluzikulu, palibe chifukwa dongosolo kasinthidwe, kupewa imfa ya zigawo zikuluzikulu ndi mkulu mamasukidwe akayendedwe monga enzyme.
Zolinga zingapo mu chubu chimodzi: chandamale chodziwikiratu chimakwirira buku la coronavirus ORF1ab jini, N jini, jini ya S kuti tipewe kufalikira kwa kachilomboka.Pofuna kuchepetsa zolakwika zabodza, jini ya RNase P yaumunthu imagwiritsidwa ntchito ngati chiwongolero chamkati, kuti akwaniritse zosowa zachipatala zowongolera khalidwe lachitsanzo.

SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (kuzindikira majini atatu) inali kale chizindikiro cha CE ku UK, ndipo tsopano yavomerezedwa ndikukonzedwa ndi EUA. FDA ku America.

Nanjing Liming Bio-Products Co., Ltd. yakhala ikuyika mtundu wa zida zoyeserera pamalo oyamba, ndipo ikuyang'ana kwambiri pakukulitsa mphamvu.Kampaniyo ipereka zida zapamwamba zoyesera za COVID-19 ndi ntchito ku mabungwe azachipatala padziko lonse lapansi, ndikuthandizira kupewa ndi kuwongolera miliri yapadziko lonse lapansi, kuti apange gulu lapadziko lonse lapansi la tsogolo logawana.

Dinani Kwanthawi yayitali ~ Jambulani ndi Kutitsatira
Imelo:sales@limingbio.com
Webusayiti: https://limingbio.com

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

Nthawi yotumiza: Jul-06-2020