Limingbio yakawana iyo anvisa kunyoreswa muBrazil uye Kunyoresa Chitupa muSingapore uye Indonesia

Limingbio yakawana iyo anvisa kunyoreswa muBrazil

Abstract
Nguva pfupi yadarika, Nanjing Loming Bio-Zvigadzirwa CO. (LTD. (Kerolimiyerm.com Panguva imwecheteyo, iyo inopfugama-cov-2 rt-2 rt-pcr uye Igg Antibody Rapid Kit yakanyorwa pane iyo yepamutemo yakakurudzirwa rondedzero yeIndonesia. Zvichakadaro, kurambidza bio yakasimba®Novel Coronavirus (Sars-Cov-2) Multiplex chaiyo-nguva PCC kombi, yakatenderwa neSypore Hutano Sayechiremera Sesimba (HSA), uye akawana chitupa cheHSA.

Limingbio yakawana iyo invisa kunyoreswa muBrazil1

Mufananidzo 1 Iyo Brazil Anvisa Certification

Brazil (anvisa) chitupa
Anvisa, anozivikanwa seAgência Nacional de vigilâricia Sanitária, ndiye brazil Medical mudziyo wekuremekedza. Izvo zvinodikanwa kuti kambani inyorwe neAnvisa, iyo National Health Supervision Agency, kutengesa zvishandiso zviri pamutemo muBrazil. Kuti usimbiswe, idzo zvishandiso zvekurapa zvinopinda muBrazil unofanirwa kuita zvinodiwa zveBrazil GMP pamwe chete nemabatiro akakosha akaiswa nevakuru veBrazil. MuBrazil, IVD zvekushandisa zvekurapa zvinozivikanwa mukirasi ini, II, III, uye IV maererano nengozi yekudzikira kusvika pakakwirira kusvika pakakwirira. Kwekirasi ini naI II Zvigadzirwa, nzira yeCadastro inotorwa, nepo yekirasi ii neIV zvigadzirwa, nzira yeRegistro inoshandiswa. Mushure mekunyoreswa kunyoreswa, nhamba yekunyoresa ichaburitswa naAnvisa, uye iyo data ichaiswa kuBrazil Medical Chishandiso Database, Iyi nhamba yekunyoresa yekunyoresa ichaonekwa paDou (Diário ofuicial da União).

Limingbio yakawana iyo invisa kunyoreswa muBrazil2
Limingbio yakawana iyo anvisa kunyoreswa muBrazil3

Mufananidzo 2 Singapore Hutano Hutano Sayenzi Chiremera (HSA) Chitupa

Limingbio yakawana iyo invisa kunyoreswa muBrazil4
Limingbio yakawana iyo anvisa kunyoreswa muBrazil6

Mufananidzo 3 Mukuru wakakurudzira mari yekutakura yeIndonesia

Limingbio yakawana iyo Anvisa yekunyoresa Chitupa muBrazil uye yakapinda muChirongwa Chekutanga Chekutanga muIndonesia6

Mufananidzo 4 Zvakasimba®Sars-cov-2 igm / igg antibody kukurumidza bvunzo

Limingbio yakawana iyo invisa kunyoreswa muBrazil7

Mufananidzo 5 Novel Coronavirus (Sars-Cov-2) Multiplex Chaizvo-Nguva PCR Kit

ONA:
Izvi zvakanyanyisa kuterera, kugadzirira-kushandisa-shandisa pccr kt kombi inowanikwa mumhando yeLyophilized fomati (kusununguka-kuoma-kuoma maitiro) yekuchengetedza kwenguva refu. Iyo kit inogona kutakurwa uye yakachengetwa pamhepo tembiricha uye yakagadzikana kwegore rimwe. Imwe neimwe tube yePramux ine ese evagadziri anodiwa kune iyo PRC Izvo zvinongoda kuwedzera 13Ul yakatsemuka mvura uye 5ul inobviswa rna template, saka inogona kumhanya uye kukwidziridzwa pane iyo PRC zviridzwa.

Iko kuoma kwekutonhora keteni yekufambisa yeNovel Coronavirus nucleic acid yekuona Reagent

Kana nguva dzose nucle acid yekuona ndege inotakurwa muhurefu hurefu, iyo (-20 ± 5) Kuti uve nechokwadi chekuti tembiricha inosvika pachiyero, kilogiramu akati wandei echando chakaoma chinodiwa kune rimwe nerimwe bhokisi re nuclec acid kuongorora kusiri pasi pe50g, mazuva maviri kana matatu chete. Pane maonero ekuita kweindasitiri maitiro, uremu chaihwo hwevatariri vakapihwa nevanogadzira pane zvisingasviki 10% (kana zvishoma zvishoma pane kukosha uku) kwemudziyo. Yakawanda yehuremu inouya kubva kune yakaoma ice, ice mapaketi uye mabhokisi emabhokisi, saka mutengo wekufambisa wakanyanya kukwirira.

Muna Kurume 2020, kuwanda-19 kwakatanga kupaza kwakakura kune imwe nyika, uye kudiwa kweNovel Coronavirus nucleic acid yekuona zvinoshamisa. Kunyangwe yakanyanya mutengo wekuendesa kunze kwenzira dzevafundisi mune inotonhora keteni, vagadziri vazhinji vanogona vachiri kugamuchira nekuda kwehuwandu hukuru uye purofiti yakakwirira.

Nekudaro, nekuvandudzwa kwezvinhu zverudzi zvekutengesa zverudzi rwekunze kwezvirongwa zvekutengesa, pamwe nekusimudzirwa kweNational Control pamusoro peVanhu uye kusagadzikana munguva yekufambisa yeReagents, iyo yakakonzerwa nematambudziko ekutanga akakonzerwa nechekufambisa. Yakatambanudzwa nguva yekufambisa Izvi zvakanetseka zvakanyanya nucle acid reagents kutumira kunze kwenyika.

Tekinoroji yeLyofilillised yePCR Reagent yakabatsirwa kufambisa kweNovel Coronavirus nucleic lection reagent pasi rose

Iyo lyeppariled pcr Regents inogona kutakurwa uye inochengeterwa pamhepo tembiricha, iyo isingagoni kungoderedza mari yekufambisa, asi zvakare dzivirira matambudziko emhando yakakonzerwa nekufambisa. Naizvozvo, lyehlizing the reagent ndiyo nzira yakanakisa yekugadzirisa dambudziko rekutakura kunze kwekufambisa.

Lyotolization inosanganisira kusunungura mhinduro kuita nyika yakasimba, uyezve nekuzviisa pasi uye kupatsanura mupfusi wemvura pasi pecuum mamiriro. Kugadziriswa kwakaomeswa kuchiramba mumudziyo pamwe nekuumbwa kwakafanana uye chiitiko. Kuenzaniswa neakajairwa maredo reagents, iyo yakazara-chikamu lyephigiryi

Yakanyanya kusimba kupisa kupisa kugadzikana: Inogona kumira kurapwa pa56】 kwemazuva makumi matanhatu, uye morphology uye kuita kwegadziriro yekuramba isina kuchinjika.
Zvakajairika kupisa chengetedzo uye chekufambisa: hapana chinodiwa cheni inotonhora, hapana chikonzero chekuchengeta pakudziya kwekushisa usati wasunungura, zvizere kuburitsa nzvimbo inotonhora yekuchengetedza.
Yaisvika-yekushandisa: Lyophizing yezvinhu zvese, hapana kudiwa kwehurongwa hwekugadziriswa, kudzivirira kurasikirwa kwezvikamu zvine zvevhu rakakwirira senge enzyme.
Multiplex tarisiro mune imwe tube: Iyo yekuona chinangwa chinofukidza Novel coronavirus orf1ab geno, n gene, s ger kuti adzivise hutachiona. Kuti uderedze nhema dzenhema, renase pra inoshandiswa seyamari yemukati, kuitira kuti usangane nekiriniki inoda sampuli yemhando yekutonga kwemhando yepamusoro.

Sars-cov-2 igg antibody rapid test uye novel coronavirus (inochengeterwa zvinhu zvitatu. of FDA muAmerica.

Nanjing Leming Bio-Zvigadzirwa C., Ltd. Agara achiisa mhando yeTest kit mune yekutanga nzvimbo, uye iri kutarisisa pakuwedzera kwekugona. Iyo kambani ichapa yakakwirira-mhando zvigadzirwa-19 kuongororwa zvigadzirwa uye masevhisi kune dzidziso dzechiremba kumativi ese epasi rose, uye zvinobatsira pakudzivirira kwepasirese uye kudzora, kuitira kuti uvake nzanga yepasi rose yeramangwana reram.

Long Press ~ Scan uye Titevedze
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Limingbio yakawana iyo Anvisa yekunyoresa Chitupa muBrazil uye yakapinda muChirongwa Chekumusoro-soro muIndonesia9

Kutumira Nguva: Jul-06-2020