Ua loaʻa iā LimingBio ka hoʻopaʻa inoa ANVISA ma Brazil a me ka palapala hoʻopaʻa inoa ma Singapore a me Indonesia

LimingBio has obtained the ANVISA registration in Brazil

ʻĀpana
I kēia mau lā, ua hōʻoia ʻia ʻo Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit e ka Brazilian National Health Supervision Bureau a loaʻa iā ia ka palapala ANVISA.I ka manawa like, ua helu pū ʻia ka SARS-CoV-2 RT-PCR a me ka IgM/IgG antibody rapid test kit ma ka papa inoa kūʻai kūʻai kūhelu ʻia o Indonesia.I kēia manawa, ʻo Liming Bio StrongStep®ʻO Novel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, ua ʻae ʻia e The Singapore Health Science Authority (HSA), a loaʻa iā ia ka palapala HSA.

LimingBio has obtained the ANVISA registration in Brazil1

Kiʻi 1 ka palapala hōʻoia ANVISA Brazil

Palakila (ANVISA) palapala hōʻoia
ʻO ANVISA, i kapa ʻia ʻo Agência Nacional de Vigilância Sanitária, ʻo ia ka mea hoʻoponopono lāʻau lapaʻau Brazilian.Pono e hoʻopaʻa inoa ʻia kahi hui me ANVISA, ka National Health Supervision Agency, e kūʻai aku i nā lāʻau lapaʻau ma ke kānāwai ma Brazil.No ka hōʻoia ʻana, pono kēlā mau lāʻau lapaʻau e komo i Brazil i nā koi o Brazilian GMP me nā kūlana kikoʻī i hoʻonohonoho ʻia e nā mana o Brazil.Ma Brazil, ua hoʻokaʻawale ʻia nā mea lapaʻau IVD i ka Papa I, II, III, a me IV e like me ka pae pilikia mai ka haʻahaʻa a i ke kiʻekiʻe.No nā huahana Class I a me II, ua hoʻohana ʻia ke ala Cadastro, ʻoiai no nā huahana Class III a me IV, hoʻohana ʻia ke ala Registro.Ma hope o ka hoʻopaʻa inoa kūleʻa, e hoʻopuka ʻia kahi helu hoʻopaʻa inoa e ANVISA, a e hoʻouka ʻia ka ʻikepili i ka waihona ʻoihana lapaʻau Brazilian, e ʻike ʻia kēia helu a me kāna ʻike hoʻopaʻa inoa e pili ana ma DOU (Diário Oficial da União).

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

Kiʻi 2 Singapore Health Science Authority (HSA) palapala hōʻoia

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

Kiʻi 3 ʻO ka papa inoa kūʻai kūʻai i ʻōlelo ʻia ma Indonesia

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

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

LimingBio has obtained the ANVISA registration in Brazil7

Kiʻi 5 Novel Coronavirus (SARS-CoV-2) Multiplex PCR kit manawa maoli

Nānā:
Loaʻa kēia pahu PCR maʻalahi a mākaukau e hoʻohana i ka format lyophilized (ka hana maloʻo maloʻo) no ka mālama lōʻihi.Hiki ke lawe ʻia a mālama ʻia ka pahu ma ka lumi wela a paʻa no hoʻokahi makahiki.Loaʻa i kēlā me kēia paipu o premix nā reagents a pau e pono ai no ka hoʻonui ʻana i ka PCR, me ka Reverse-transcriptase, Taq polymerase, primers, probes, a me nā substrate dNTPs.Pono e hoʻohui i 13ul wai distilled a me 5ul extracted RNA template, a laila hiki ke holo a hoʻonui ʻia ma nā mea kani PCR.

ʻO ka paʻakikī o ka lawe ʻana i ke kaulahao anu o Novel Coronavirus nucleic acid detection reagent

Ke lawe ʻia nā reagents ʻike nucleic acid ma kahi lōʻihi, ʻo ka (-20 ± 5) ℃ ka mālama ʻana i ke kaulahao anuanu a me ka lawe ʻana e koi ʻia e hōʻoia i ka bioactive o ka enzyme i loko o nā reagents.No ka hōʻoia i ka hiki ʻana o ka mahana i ka maʻamau, pono ʻia he mau kilokani hau maloʻo no kēlā me kēia pahu o ka nucleic acid hoʻāʻo reagent ʻoi aku ka liʻiliʻi ma mua o 50g, akā hiki ke mau no ʻelua a ʻekolu mau lā.Ma ka manaʻo o ka hana ʻoihana, ʻo ke kaumaha maoli o nā reagents i hoʻopuka ʻia e nā mea hana ma lalo o 10% (a i ʻole ka liʻiliʻi ma mua o kēia waiwai) o ka ipu.ʻO ka hapa nui o ke kaumaha mai ka hau maloʻo, nā pahu hau a me nā pahu pahu, no laila ke kiʻekiʻe loa ke kumukūʻai.

I Malaki 2020, ua hoʻomaka ʻo COVID-19 i kahi ākea nui ma waho, a ua piʻi nui ka noi no ka Novel Coronavirus nucleic acid detection reagent.ʻOiai ke kumukūʻai kiʻekiʻe o ka lawe ʻana aku i nā reagents i ke kaulahao anu, hiki i ka hapa nui o nā mea hana ke ʻae iā ia ma muli o ka nui a me ka loaʻa kālā kiʻekiʻe.

Eia nō naʻe, me ka hoʻomaikaʻi ʻana i nā kulekele hoʻopuka aupuni no nā huahana anti-pandemic, a me ka hoʻonui ʻana i ka mana aupuni ma luna o ke kahe o ka poʻe a me ka logistic, aia ka hoʻonui a me ka maopopo ʻole i ka manawa o ka lawe ʻana i nā reagents, i hopena i nā pilikia huahana koʻikoʻi. e ka halihali ana.ʻO ka lōʻihi o ka lawe ʻana i ka manawa (he mea maʻamau ka manawa o ka lawe ʻana ma kahi o ka hapalua mahina) alakaʻi i ka hāʻule pinepine ʻana o ka huahana ke hiki aku ka huahana i ka mea kūʻai.Ua pilikia kēia i ka hapa nui o nā ʻoihana hoʻoiho nucleic acid reagents.

Ua kōkua ka ʻenehana Lyophilized no ka PCR reagent i ka lawe ʻana i ka Novel Coronavirus nucleic acid detection reagent ma ka honua holoʻokoʻa.

Hiki ke lawe ʻia a mālama ʻia nā lyophilized PCR reagents i ka lumi lumi, ʻaʻole hiki ke hōʻemi wale i ke kumukūʻai o ka lawe ʻana, akā pale pū nō hoʻi i nā pilikia maikaʻi i hoʻokumu ʻia e ke kaʻina kaʻa.No laila, ʻo ka lyophilizing ka reagent ke ala maikaʻi loa e hoʻoponopono ai i ka pilikia o ka lawe ʻana aku i waho.

Hoʻopili ka Lyophilization i ka hoʻoheheʻe ʻana i kahi hopena i loko o kahi kūlana paʻa, a laila hoʻohaʻahaʻa a hoʻokaʻawale i ka mahu wai ma lalo o ke ʻano ʻūhā.Noho ka solute maloʻo i loko o ka pahu me ka hana like a me ka hana.Hoʻohālikelike ʻia me nā reagents wai maʻamau, ʻo ka piha piha lyophilized Novel Coronavirus nucleic acid detection reagent i hana ʻia e Liming Bio i kēia mau hiʻohiʻona:

ʻO ke kūpaʻa wela ikaika loa: hiki iā ia ke kū me ka mālama ʻana ma 56 ℃ no 60 mau lā, a ʻaʻole i loli ka morphology a me ka hana o ka reagent.
ʻO ka mālama ʻana i ka mahana maʻamau a me ka lawe ʻana: ʻaʻohe pono o ke kaulahao anu, ʻaʻohe pono e mālama i ka haʻahaʻa haʻahaʻa ma mua o ka wehe ʻana, hoʻokuʻu piha i ka wahi mālama anu.
Mākaukau-e hoʻohana: lyophilizing o nā mea a pau, ʻaʻohe pono no ka hoʻonohonoho ʻana o ka ʻōnaehana, pale i ka nalowale o nā ʻāpana me ka viscosity kiʻekiʻe e like me ka enzyme.
ʻO nā pahuhopu lehulehu i loko o hoʻokahi paipu: uhi ka pahu hopu ʻike i ka novel coronavirus ORF1ab gene, N gene, S gene e pale aku i ka maʻi genovariation.I mea e hōʻemi ai i ka hewa hewa, hoʻohana ʻia ke kanaka RNase P gene ma ke ʻano he mana kūloko, i mea e hoʻokō ai i ka pono lapaʻau no ka hoʻokele maikaʻi ʻana.

ʻO SARS-CoV-2 IgM/IgG Antibody Rapid Test a me Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (ʻike ʻia no ʻekolu mau genes) ua hōʻailona mua ʻia ʻo CE ma UK, a ua ʻae ʻia a ke hana ʻia nei e EUA. o ka FDA ma Amerika.

Ua kau mau ʻo Nanjing Liming Bio-Products Co., Ltd. i ka maikaʻi o ka pahu hoʻāʻo ma kahi mua, a ke kau nei i ka hoʻonui ʻana i ka hiki.E hāʻawi ka hui i nā huahana a me nā lawelawe hoʻāʻo COVID-19 kiʻekiʻe i nā keʻena olakino a puni ka honua, a hāʻawi i ka pale ʻana i ka maʻi maʻi honua, i mea e kūkulu ai i kahi kaiāulu honua o ka wā e hiki mai ana.

Paʻi lōʻihi~Scan and Follow us
leka uila:sales@limingbio.com
Paena pūnaewele: https://limingbio.com

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

Ka manawa hoʻouna: Jul-06-2020