LimingBio yakawana kunyoreswa kweANVISA muBrazil uye chitupa chekunyoresa muSingapore neIndonesia

LimingBio has obtained the ANVISA registration in Brazil

Abstract
Munguva pfupi yapfuura, Nanjing Liming Bio-Products Co., Ltd. (www.limingbio.com)SARS-CoV-2 lgM/IgG Antibody Rapid Test Kit yakasimbiswa neBrazilian National Health Supervision Bureau uye yakawana chitupa cheANVISA.Panguva imwecheteyo, iyo SARS-CoV-2 RT-PCR uye IgM/IgG antibody yekukurumidza bvunzo kit zvakare yakanyorwa pane yepamutemo yakakurudzirwa yekutenga rondedzero yeIndonesia.Zvichakadaro, Liming Bio StrongStep®Novel Coronavirus (SARS-CoV-2) Multiplex Real-time PCR Kit, yakatenderwa neThe Singapore Health Sciences Authority (HSA) , ikawana chitupa cheHSA.

LimingBio has obtained the ANVISA registration in Brazil1

Mufananidzo 1 weBrazil ANVISA certification

Brazil (ANVISA) certification
ANVISA, inozivikanwa seAgência Nacional de Vigilância Sanitária, ndiye anodzora mudziyo wekurapa wekuBrazil.Izvo zvinodiwa kuti kambani inyoreswe neANVISA, iyo National Health Supervision Agency, kutengesa michina yekurapa zviri pamutemo muBrazil.Kuti zvibvumidzwe, izvo zvigadzirwa zvekurapa zvinopinda muBrazil zvinofanirwa kuzadzisa zvinodiwa zveBrazilian GMP pamwe chete nematanho akatarwa nevakuru veBrazil.MuBrazil, IVD michina yekurapa inoiswa muKirasi I, II, III, uye IV zvichienderana nedanho renjodzi kubva pasi kusvika kumusoro.Kune zvigadzirwa zveKirasi I uye II, nzira yeCadastro inotambirwa, nepo kune zvigadzirwa zveKirasi III neIV, nzira yeRegistro inoshandiswa.Mushure mekubudirira kunyoreswa, nhamba yekunyoresa ichapihwa neANVISA, uye iyo data ichaiswa kuBrazilian medical device database, iyi nhamba uye inowirirana ruzivo rwekunyoresa ichaonekwa paDOU (Diário Oficial da União).

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

Mufananidzo 2 Singapore Hutano Sayenzi Chiremera (HSA) chitupa

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

Mufananidzo 3 Mukuru akakurudzira rondedzero yekutenga yeIndonesia

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

Mufananidzo 4 Nhanho Yakasimba®SARS-CoV-2 IgM/IgG Antibody Rapid Test

LimingBio has obtained the ANVISA registration in Brazil7

Mufananidzo 5 Novel Coronavirus (SARS-CoV-2) Multiplex Chaiyo-Nguva PCR kit

Cherechedza:
Iyi PCR kit inonzwisisika zvakanyanya, yakagadzirira kushandisa inowanikwa mu lyophilized fomati (kuomesa-kuomesa) kuchengetedza kwenguva refu.Iyo kiti inogona kutakurwa uye kuchengetwa mukamuri tembiricha uye inogadzikana kwegore rimwe.Imwe neimwe chubhu ye premix ine ese mareagents anodiwa pakukwidziridzwa kwePCR, kusanganisira Reverse-transcriptase, Taq polymerase, primers, probes, uye dNTPs substrates.Inongoda kuwedzera 13ul mvura yakasvibiswa uye 5ul yakabviswa RNA template, ipapo inogona kumhanya uye kukwidziridzwa paPCR zviridzwa.

Kuoma kwekutonhora kwekutakura cheni yeNovel Coronavirus nucleic acid yekuona reagent

Kana yakajairwa nucleic acid yekuona reagents inotakurwa kure kure, iyo (-20 ± 5) ℃ inotonhora cheni yekuchengetedza uye yekufambisa inodiwa kuti ive nechokwadi chekuti bioactive ye enzyme mune reagents inoramba ichishanda.Kuti uve nechokwadi chekuti tembiricha inosvika pachiyero, makirogiramu akati wandei echando chakaoma anodiwa pabhokisi rega rega reiyo nucleic acid yekuongorora reagent kunyange isingasviki 50g, asi inogona kungogara kwemazuva maviri kana matatu.Pamaonero ekuita kweindasitiri, huremu chaihwo hwemareagents akapihwa nevagadziri huri pasi pegumi muzana (kana kure kure kupfuura kukosha uku) kwemudziyo.Huremu huzhinji hunobva muchando chakaoma, ice packs uye furo mabhokisi, saka mutengo wekufambisa wakakwira zvakanyanya.

Muna Kurume 2020, COVID-19 yakatanga kubuda pamwero mukuru kunze kwenyika, uye kudiwa kweNovel Coronavirus nucleic acid yekuona reagent kwakawedzera zvakanyanya.Kunyangwe nemutengo wakakwira wekutengesa kunze ma reagents mucheni inotonhora, vazhinji vanogadzira vanogona vachiri kuigamuchira nekuda kwehuwandu hukuru uye purofiti yakakura.

Nekudaro, nekuvandudzwa kwemitemo yenyika kunze kwenyika yezvigadzirwa zvinorwisa denda, pamwe nekuvandudzwa kwekutonga kwenyika pamusoro pekuyerera kwevanhu uye zvinhu, kune kuwedzera uye kusava nechokwadi munguva yekufambisa yemareagents, izvo zvakakonzera matambudziko ane mukurumbira echigadzirwa akakonzerwa. nechokufambisa.Yakawedzerwa nguva yekufambisa (nguva yekufambisa ingangoita hafu yemwedzi yakajairika) inotungamira mukutadza kwechigadzirwa kazhinji kana chigadzirwa chasvika kune mutengi.Izvi zvanetsa mazhinji nucleic acid reagents ekunze mabhizinesi.

Lyophilized tekinoroji yePCR reagent yakabatsira kufambisa kweNovel Coronavirus nucleic acid yekuona reagent pasi rese.

Iyo lyophilized PCR reagents inogona kutakurwa uye kuchengetwa mukamuri tembiricha, izvo zvisingagone chete kuderedza mutengo wekufambisa, asi zvakare kudzivirira matambudziko emhando anokonzerwa nemaitiro ekufambisa.Naizvozvo, lyophilizing iyo reagent ndiyo nzira yakanakisa yekugadzirisa dambudziko rekutakura kunze kwenyika.

Lyophilization inosanganisira kuomesa mhinduro mune yakasimba mamiriro, uyezve sublimate uye kuparadzanisa mhute yemvura pasi pevacuum mamiriro.Iyo yakaomeswa solute inoramba iri mumudziyo ine yakafanana kuumbwa uye basa.Kuenzaniswa neyakajairwa mvura reagents, iyo yakazara-chikamu lyophilized Novel Coronavirus nucleic acid yekuona reagent inogadzirwa neLiming Bio ine zvinotevera maitiro:

Yakanyanya kusimba kupisa kugadzikana: inogona nekumira kurapwa pa56 ℃ kwemazuva makumi matanhatu, uye morphology uye kuita kweiyo reagent inoramba isingachinji.
Yakajairika tembiricha yekuchengetedza uye yekufambisa:hapana kudikanwa kwekutonhora cheni, hapana chikonzero chekuchengeta pane yakaderera tembiricha isati yavhurwa, sunungura zvizere nzvimbo yekuchengetera inotonhora.
Yakagadzirira-kushandisa: lyophilizing yezvikamu zvose, hapana chikonzero chekugadzirisa hurongwa, kudzivisa kurasikirwa kwezvikamu zvine high viscosity yakadai se enzyme.
Multiplex tarisiro muchubhu imwe: iyo yekuona tarisiro inovhara novel coronavirus ORF1ab gene, N gene, S gene kudzivirira hutachiona genovariation.Kuti uderedze nhema dzisina kunaka, RNase P gene yemunhu inoshandiswa sekutonga kwemukati, kuitira kuti isangane nekiriniki yekuda kwemuenzaniso wekutonga kwemhando.

SARS-CoV-2 IgM/IgG Antibody Rapid Test uye Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit (yekuonekwa kwemajini matatu) yakambove CE yakamaka muUK, uye ikozvino yakagamuchirwa uye ichigadziriswa neEUA. yeFDA muAmerica.

Nanjing Liming Bio-Products Co., Ltd. yagara ichiisa mhando yetest kit munzvimbo yekutanga, uye iri kutarisa pakuwedzera kwesimba.Iyo kambani ichapa emhando yepamusoro COVID-19 yekuyedza zvigadzirwa uye masevhisi kumasangano ekurapa pasi rese, uye nekupa mukudzivirira nekudzora denda repasi rose, kuitira kuvaka nharaunda yepasi rose yeramangwana rakagovaniswa.

Dzvanya Yakareba ~ Scan uye Titevere
Email:sales@limingbio.com
Webhusaiti: https://limingbio.com

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

Nguva yekutumira: Chikunguru-06-2020