I-Lillingbio ifumene ubhaliso lwe-ANVISA kwiSatifikethi soBhaliso kwiSingapore nakwiIndonesia

I-Lingbio ifumene ubhaliso lwe-ANVISA kwiBrazil

Nqabile
Kutshanje, i-zungung ye-bio-iimveliso com. Kwangelo xesha, i-SARS-2 RT-2 rt-prr kunye ne-Igm / i-Igg Anti kikhi ye-Igm ye-Igm ikwadweliswa kuluhlu lwaseburhulumenteni lwe-Indonesia. Okwangoku, ukuthambeka komelele®I-Noves Coronavirus (i-SARS-CoV-2) I-Interp ye-PCR ye-PCR Kit, yavunywa nguMgunyazisi weSayensi wezeMpilo (HSA), wafumana isatifikethi se-HSA.

I-Lingbio ifumene ubhaliso lwe-ANVISA kwi-brazil1

Umfanekiso okwiphepha 1 Isiqinisekiso se-anvil savisa

Isiqinisekiso se-Brazil (Anvisa)
I-Anvisa, eyaziwa ngokuba yi-agência nacy de vigâconcia sanária, ngumlawuli wesixhobo saseBrazil. Kuyimfuneko ukuba inkampani ibhaliswe kwi-ANVASA, i-Arhente yeNdawo yeSizwe, yokuthengisa izixhobo zonyango eBrazil. Ukuqinisekiswa, ezo zixhobo zezonyango ezingena eBrazil kufuneka zifezekise iimfuno ze-gmp yaseBrazil kunye nemigangatho ethile esekwe ngabasemagunyeni beBrazil. Kwi-Brazil, izixhobo zezonyango ze-IVD zihlelwa eklasini i, II, i-III, kunye ne-IV ngokwenqanaba lomngcipheko ukusuka ezantsi ukuya phezulu. Kudidi I kunye ne-II kunye II kunye neI kunye ne-CADARAROARTRO yamkelwe, ngelixa i-IV yeemveliso ze-IV, indlela yeRegistro isetyenziswe. Emva kokubhaliswa ngempumelelo, inombolo yobhaliso iya kukhutshwa yi-ANVASA, kwaye idatha iya kulayishwa kwisiseko sedatha ye-Brazil, le nombolo kunye nolwazi lwalo lokubhalisa luya kuvela kwi-Dou

I-Lingbio ifumene ubhaliso lwe-ANVISA eBrazil2
I-Lingbio ifumene ubhaliso lwe-ANVISA eBrazil3

Umfanekiso we-2 ISICWANGCISO SOKUFAKWA KWESICWANGCISO SEZEMPILO (HSA) Isiqinisekiso se-HSA)

I-Lingbio ifumene ubhaliso lwe-ANVISA eBrazil4
I-Lingbio ifumene ubhaliso lwe-ANVISA eBrazil6

Umfanekiso 3 ULuhlu lweSoftware olwenziwe ngokuBalulekileyo lwe-Indonesia

I-Lightbio ifumene isatifiketi sobhaliso lwe-ANDASA eBrazil sangena kuluhlu lokuthengwa okusemthethweni kwi-Indonesia6

Imifanekiso ye-4®I-SARS-cov-2 IGM / IGG i-Anti yovavanyo olukhawulezayo

I-Lingbio ifumene ubhaliso lwe-ANVISA kwi-brazil7

Umfanekiso we-5 Noves Coronavirus (i-SARS-CoV-2) I-CountsX ye-PCR ye-PCR ye-PCR

Phawula:
Oku kunovelwano kakhulu, ukulungiselela-ukusebenzisa i-PCR Kit kuyafumaneka kwifomathi ye-LINOPILL (inkqubo eyomisayo) yesitorengi sexesha elide. Ikhithi inokuhanjiswa kwaye igcinwe kubushushu begumbi kwaye ihlale unyaka omnye. Ityhubhu nganye ye-PREMIS iqulethe zonke iiRegentnts eziyimfuneko kwi-PCR SOTLPPECET, i-TAQ Polymerase, iTaq Polymerase, i-Primes, iPiples Protenation. Ifuna kuphela i-velul mail kwaye i-5ul ikhuphe i-template ye-RNA yeRNA, ke inokuqhutywa kwaye ikhuliswe kwizixhobo ze-PCR.

Ubunzima bokuhamba kwentambo kubandayo kweNovel Coronavirus Nucleid I-Acid Recring

Xa i-Inycleid eqinisekisiweyo ye-Inycleid ihanjisiwe kumgama omde, (-20 ± 5) Ukuqinisekisa ukuba iqondo lobushushu lifikelela kwimigangatho, iikhilogramu ezininzi zomkhenkce owomileyo ziyafuneka kwibhokisi nganye yovavanyo lwe-scid reagent ukuphinda isebenze kangako kangange-50 okanye i-3 okanye ezintathu kuphela. Ngombono wokuziqhelanisa nokuziqhelanisa, ubunzima bokuphinda-phinda abakhutshwe ngabavelisi bungaphantsi kwe-10% (okanye ngaphantsi kweli xabiso) sesitya. Uninzi lobunzima luvela kumkhenkce owomileyo, iipakethi zomkhenkce kunye neebhokisi ze-foam, ke iindleko zothutho ziphezulu kakhulu.

Ngo-Matshi ka-2020, Codd-19 waqalisa ukuphuma kwinqanaba elikhulu laphesheya, kwaye imfuno yeNovel Cooves Coovrigus inycleic inyuke ngokungxamisekileyo. Ngaphandle kweendleko eziphezulu zokuthumela i-Regentants kwindawo ebandayo, uninzi lwabavelisi basenokuyamkela ngenxa yenani elikhulu kunye nenzuzo ephezulu.

Nangona kunjalo, ngokuphuculwa kwemigaqo-nkqubo yokuthengiselwa ngaphandle yelizwe kwiimveliso ze-anti-pandemic, kunye nokuphuculwa kolawulo lukazwelonke malunga nokuhamba kwabantu kunye nezinto, kukho ukongezwa kunye nokungaqiniseki ngexesha lokuhamba, elibangelwe kwiingxaki zemveliso ezibangelwe ngothutho. Ixesha lokuThutha elandisiweyo (Ixesha lokuThutha malunga nesiqingatha senyanga siqhelekileyo kakhulu) sikhokelela ekungathobeleni imveliso xa imveliso ifikelela kumthengi. Oku kukhathaza uninzi lwamashishini okuthumela ngaphandle.

Itekhnoloji yeLiophilble ye-PCR Reagent yanceda ukuthuthwa kweNovel Coronavirus Nucleid I-Acid Sygent Studnt Shogent Suger

I-LyOphilvents PRR Regeents ingahanjiswa kwaye igcinwe kubushushu begumbi, engenakukwazi ukunciphisa iindleko zothutho, kodwa kukuphepha iingxaki ezisemgangathweni ezibangelwa yinkqubo yokuhamba. Ke ngoko, iLiophilbuble i-Regent yeyona ndlela ilungileyo yokusombulula ingxaki yokuthengisa ngaphandle.

I-Loophilization ibandakanya ukukhulula isisombululo kwisimo esiqinileyo, emva koko sanda kwaye sahlule umphunga wamanzi phantsi kwemeko ye-vacuum. Isinyibiliki esomileyo sihlala kwisitya kunye nomsebenzi ofanayo kunye nomsebenzi. Xa kuthelekiswa neeRegint eziQhelekileyo zeRhafu, iCandelo leLicophil Soronavirus ye-Invelius Nucleid I-Acid Reagent Remoge evelisiweyo eveliswe yi-bing bing ineempawu ezilandelayo:

Uzinzo oluqinileyo kakhulu
Ukugcinwa kobushushu obuqhelekileyo kunye nokuhamba: Akukho sidingo sokubanda kwe-chain, akukho sidingo sokugcina kubushushu obuphantsi ngaphambi kokuba kungangeniswanga, khupha ngokupheleleyo indawo yokugcina amanzi.
Ukuzisebenzisa
Iithagethi ze-Auntisx kwi-Tube enye: Ukufunyanwa kwethagethi kujolise kwiNovel Coronavirus Orf1ab1ab, Nten, n gene, simele ukuphepha intsholongwane. Ukwenzela ukunciphisa ubuxoki, i-gene yoluntu isetyenziswa njengolawulo lwangaphakathi, ukuze kuhlangatyezwane nemfuno yekliniki yolawulo lomgangatho.

I-SARS-cov-2 IGM ye-FDA eMelika.

I-NanunJing I-Bio-Iimveliso CO. Inkampani iza kubonelela ngeemveliso ezikumgangatho ophezulu-19 kunye neenkonzo kunye neenkonzo kumaziko ezonyango kwihlabathi liphela, kwaye zibe negalelo ekuthinteleni ukhuseleko lwehlabathi kunye nokulawula, ukuze kwakhiwe abantu kwihlabathi liphela.

Cofa ixesha elide ~ Scan kwaye ulandele
I-imeyile:sales@limingbio.com
Iwebhusayithi ::plimingbio.com

I-Lightbio ifumene isatifiketi sobhaliso lwe-ANVISA eBrazil sangena kuluhlu lokuthengwa kwempahla ngokusemthethweni kwi-Indonesia9

IXESHA LOKUQALA: UJUL-06-20202020