Kua whiwhi a LimingBio te rehitatanga ANVISA i Brazil me te tiwhikete rehitatanga i Singapore me indonesia

LimingBio has obtained the ANVISA registration in Brazil

Putanga
I tata nei, Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit kua whakamanahia e te Brazilian National Health Supervision Bureau me te whiwhi tohu ANVISA.I te wa ano, ko te SARS-CoV-2 RT-PCR me te IgM/IgG antibody kete whakamatautau tere kei te raarangi i runga i te raarangi hoko whai mana o Indonesia.I tenei wa, Liming Bio StrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex PCR Waa-tūturu Kete, i whakaaetia e te Singapore Health Sciences Authority (HSA), ka whiwhi i te tiwhikete HSA.

LimingBio has obtained the ANVISA registration in Brazil1

Pikitia 1 te Tiwhikete ANVISA Brazil

Brazil (ANVISA) Tiwhikete
Ko ANVISA, e mohiotia ana ko Agência Nacional de Vigilância Sanitária, ko te kaiwhakahaere taputapu rongoa Brazilia.He mea tika kia rehitatia tetahi kamupene me ANVISA, te National Health Supervision Agency, ki te hoko i nga taputapu rongoa ki Brazil.Hei whakamana, ko aua taputapu rongoa ka uru ki Brazil me tutuki nga whakaritenga a Brazilian GMP me nga paerewa motuhake kua whakaritea e nga mana whakahaere o Brazil.I Brazil, ka whakarōpūhia nga taputapu rongoa IVD ki te Class I, II, III, me IV i runga i te taumata orearea mai i te iti ki te teitei.Mo nga hua o te Class I me te II, ka whakamahia te huarahi Cadastro, engari mo nga hua Class III me IV, ka whakamahia te huarahi Registro.I muri i te rehitatanga angitu, ka tukuna he nama rehitatanga e ANVISA, ka tukuna nga raraunga ki te paataka rongoa rongoa Brazilia, ka puta tenei nama me ona korero rehitatanga e rite ana ki te DOU (Diário Oficial da União).

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

Pikitia 2 Tiwhikete a Singapore Health Sciences Authority (HSA).

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

Pikitia 3 Ko te rarangi hoko whaimana e taunakitia ana mo Indonesia

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

Pikitia 4 StrongStep®SARS-CoV-2 IgM/IgG Antibody Rapid Test

LimingBio has obtained the ANVISA registration in Brazil7

Pikitia 5 Novel Coronavirus (SARS-CoV-2) Multiplex Wā-tūturu kete PCR

Tuhipoka:
Ko tenei kete PCR tino tairongo, rite-ki-te whakamahi e waatea ana i roto i te whakatakotoranga lyophilized (te whakamaroke whakatio) mo te rokiroki mo te wa roa.Ka taea te kawe me te penapena i te kete ki te pāmahana rūma, ka pumau mo te tau kotahi.Kei ia ngongo o premix nga reagents katoa e hiahiatia ana mo te whakakaha PCR, tae atu ki te Reverse-transcriptase, Taq polymerase, primers, probes, me nga taputapu dNTPs.Me taapiri noa te 13ul wai makuku me te 5ul te tauira RNA kua tangohia, katahi ka taea te whakahaere me te whakakaha ki runga i nga taputapu PCR.

Ko te uaua o te kawe mekameka makariri o Novel Coronavirus te reagent detection acid nucleic acid

I te wa e haria ana nga reagents rapunga waikawa karihi tikanga i tawhiti, ko te (-20±5) ℃ te rokiroki mekameka makariri me te kawe ka hiahiatia kia noho kaha te koiora o te enzyme i roto i nga reagents.Hei whakarite kia eke te pāmahana ki te paerewa, he maha nga kirokaramu tio maroke e hiahiatia ana mo ia pouaka o te reagent whakamatautau waikawa karihi ahakoa iti iho i te 50g , engari ka taea mo te rua, e toru nga ra anake.I runga i te tirohanga o nga mahi ahumahi, ko te tino taumaha o nga reagents i tukuna e nga kaihanga he iti iho i te 10% (he iti ake ranei i tenei uara) o te ipu.Ko te nuinga o te taumaha ka ahu mai i te hukapapa maroke, nga kete hukapapa me nga pouaka pahuka, no reira he nui te utu o te kawe.

I te Poutu-te-rangi 2020, i timata te COVID-19 ki te pakaru i roto i te waahanga nui ki waho, me te tono mo te Novel Coronavirus nucleic acid detection reagent.Ahakoa te utu nui o te kaweake i nga reagents i roto i te mekameka makariri, ka taea tonu e te nuinga o nga kaihanga te whakaae na te nui o te nui me te nui o te hua.

Heoi, na te whakapai ake o nga kaupapa here kaweake a motu mo nga hua anti-pandemic, me te whakapai ake i te mana whakahaere o te motu mo te rere o te tangata me te arorau, he toronga me te koretake o te wa kawe o nga reagents, i puta ai nga raru hua nui. na te kawe waka.Ko te roanga o te wa kawe (he mea noa te wa kawe mo te haurua marama) ka paheke te hua ina tae atu te hua ki te kaihoko.Na tenei i whakararuraru i te nuinga o nga hinonga kaweake waikawa nucleic reagents.

Ko te hangarau lyophilized mo te reagent PCR i awhina i te kawe o te Novel Coronavirus te reagent kitenga waikawa karihi huri noa i te ao.

Ko nga reagents PCR lyophilized ka taea te kawe me te rongoa i te pāmahana rūma, kaore e taea te whakaiti noa i te utu waka, engari ka karo ano hoki i nga raru o te kounga i puta mai i nga mahi kawe.Na reira, ko te lyophilizing te reagent te huarahi pai ki te whakaoti i te raru o te kawe kawe kawe.

Ko te lyophilization ko te whakatio i tetahi otinga ki roto i te ahua totoka, ka whakamaarama ka wehe i te kohu wai i raro i te ahua korehau.Ka noho tonu te wairewa maroke ki roto i te ipu he rite tonu te hanga me te mahi.Ka whakatauritea ki nga reagents wai tikanga, ko te lyophilized Novel Coronavirus te reagent detection acid nucleic acid i hangaia e Liming Bio e whai ake nei:

Tino kaha te whakapumautanga o te wera: ka taea ki te tu maimoatanga i te 56 ℃ mo nga ra 60, ka noho tonu te ahua me te mahi o te reagent.
Te rokiroki o te pāmahana me te kawe waka: karekau he hiahia mo te mekameka makariri, kaore he take ki te penapena i te pāmahana iti i mua i te wetewete, ka tukuna katoatia te waahi rokiroki makariri.
Riri-ki-te whakamahi: lyophilizing o ngā wāhanga katoa, kahore he take mo te whirihoranga pūnaha, karo i te ngaro o ngā wāhanga ki te pokey tiketike pērā i whākōkī.
Nga whaainga maha i roto i te ngongo kotahi: ka kapi te ira o te coronavirus ORF1ab, te ira N, te ira S ki te karo i te whakaraeraetanga huaketo.Hei whakaiti i te kino kino, ka whakamahia te ira RNase P tangata hei mana o roto, kia tutuki ai te hiahia haumanu mo te mana kounga tauira.

SARS-CoV-2 IgM/IgG Antibody Rapid Test and Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (te kimi mo nga ira e toru) kua tohua i mua i te tohu CE i te UK, inaianei kua whakaaetia, kei te whakahaeretia e EUA. o FDA i Amerika.

Ko Nanjing Liming Bio-Products Co., Ltd. kua tuu i nga wa katoa te kounga o te kete whakamatautau ki te waahi tuatahi, me te aro ki te roha o te kaha.Ka whakawhiwhia e te kamupene nga hua me nga ratonga whakamatautau COVID-19 ki nga whare rongoa puta noa i te ao, me te whai waahi ki te aukati me te whakahaere i nga mate uruta o te ao, kia pai ai te hanga i tetahi hapori o te ao mo nga mea kei te heke mai.

Pehi roa~Matawai me te whai i a matou
Īmēra:sales@limingbio.com
Paetukutuku: https://limingbio.com

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

Wā tuku: Hūrae-06-2020