Nguva pfupi yadarika, Nanjing LimingBio's Novel Coronavirus (SARS-CoV-2) antigen yekuona reagent "StrongStep® SARS-CoV-2 Antigen Rapid Test" yakawana humbowo hwekuita kwePaul-Ehrlich-Institut (PEI*) kuGermany, chigadzirwa ichi chave. yakasimbiswa neGerman Federal Agency yeMishonga uye Medical Device Administration (BfArM).LimingBio yave imwe yevashoma vagadziri muChina vakawana mbiri mbiri yeBfArM + PEI kuGermany.Iyo Liming Bio's antigen yekukurumidza bvunzo yakapfuura certification yeBazi reHutano renyika dzakawanda, izvo zvinonyatso ratidza kushanda kwakanaka kwekiti.
Liming Bio's antigen yekukurumidza bvunzo yakabudirira kupfuura German PEI performance verification
PS PEI: Paul Ehrlich Institute (German: Paul-Ehrlich-Institut), inozivikanwawo seGerman Federal Institute of Vaccines uye Biomedicine, inzvimbo yekutsvagisa uye yekurapa inodzora agency yeGerman Federation, parizvino iri pasi peFederal Ministry of Health (BMG). ), ine mashandiro akazvimirira ekuongorora chigadzirwa chebiological, mvumo yekuyedzwa kwekiriniki, kubvumidzwa kwechigadzirwa uye kushambadzira, uye kuburitsa batch.Panguva imwecheteyo, inoitawo kunyora, kudzokororwa kwemitemo yakakodzera, uyeprovideszano resainzi kumasangano akasiyana, kunyanya dzimwe nyika dzeEuropean Union, European Union nemakomiti epasirese.Auye, izviprovidesmazano eunyanzvi kuhurumende yeGermany, masangano emunharaunda neparamende, uye kupasruzivo rwakakosha kune varwere nevatengi.
Liming Bio's antigen yekukurumidza bvunzo yakabudirira kupasa chitupa cheGerman BfArM
Iyo StrongStep® SARS-CoV-2 Antigen Rapid Test yakagadziridzwa naNanjing Liming Bio yakawana zvakatevedzana European Union CE certification, iyo China National Institute for Food and Drug Control yekuongorora yekuongorora (NIFDC) yekuongorora, yakapinda muRockefeller Foundation yakakurudzirwa runyorwa, uye Guatemala. chitupa , Italian Ministry of Health certification, chitupa cheGerman, chitupa cheEcuador, Brazil (ANVISA) chitupa, Chile chitupa, Argentina chitupa, Dominica certification, Guatemala certification, Singapore HSA chitupa, Malaysia (MDA) chitupa, Philippines FDA certification, Thailand FDA certification, Thailand certification.Yakakunda kurumbidzwa mukuongororwa kwakazvimirira kweBritish Dhipatimendi reHutano neHuman Services (DHSC) uye (British AAA certification).
Malaysia MDA Novel Coronavirus Antigen Self-Test Chitupa
Zvimiro uye zvakanakira
01 Yakanaka sampling: isiri-invasive sampuli yekuunganidza, mate kana nasopharyngeal swab.
02 Kukurumidza kuona: Iyo yese yekuona maitiro inongotora maminetsi gumi nemashanu, uye mhedzisiro inoonekwa zvakananga nemeso.
03 Kushanda kuri nyore: Inogona kushandirwa pasina chero midziyo yekubatsira uye pasina ruzivo.
04 Kuita kwakanakisa: chaiyo ndeye 99.26%, senitivity ndeye 96.2%, uye iko kurongeka kuri 95%.
05 Kuda kugadzirisa: Parizvino, kambani ine nyanzvi yezvokurapa shanduro, kumba self-test (mate + nasopharyngeal swab) shanduro uye Mini self-test version, etc. Bhokisi rekuputira nemirayiridzo inogona kugadziriswa maererano nezvinodiwa nevatengi.
Iyi Sisitimu Chishandiso cheSARS-CoV-2 Antigen Rapid Test (peni rudzi) ine biological kuchengetedza kuchengetedza mudziyo, unogona kunyatsovharisa hutachiona mumuenzaniso wekugadzirisa mhinduro kubva mukuputsika mumhepo, kusvibisa nharaunda, uye nekudzivirira nemazvo. opareta panguva yekuonekwa kweSARS-CoV-2 antigen nekukurumidza bvunzo.
Mamiriro ezvinhu edenda repasi rose achiri kunetsa.Nekubuda nekupararira kwezvakasiyana zveNovel Coronavirus hutachiona, mamiriro edenda munyika zhinji nematunhu awedzera, uye kudzivirira nekudzora kuedza kuri kutarisana nematambudziko makuru.Iyo SARS-CoV-2 Antigen Rapid Test inokurumidza, yakarurama, iri nyore kushandisa, uye inoda midziyo yakaderera uye vashandi.Inonyatsokodzera kukurumidza kuferefetwa kwenyaya dzinofungidzirwa dzehombe huru yekorona hutachiona hwehutachiona, uye inonyanya kushanda pakukurumidza kuongororwa kweiyo concentrated kuputika.Inogona kushandiswa senzira yekutanga yekudzivirira yekudzivirira denda, inoshandiswa pakuonekwa kwehutachiona hwepakutanga, kubatsira kudzivirira nekudzivirira denda, nekudzora kupararira kwehutachiona.
Nanjing Liming Bio-products Co., Ltd. yakavambwa muna 2001. Ikambani yebiological diagnostic kambani inyanzvi mukutsvagisa nekusimudzira, kugadzira uye kutengesa kwekiriniki microbial in vitro diagnostic reagents.Iine makore makumi maviri emhando yepamusoro uye yakaunganidza yakakwana yemhando system, uye yakawana IS013485 certification.Ma manejimendi ekugadzira anomhanya zvinoenderana nepasirese mhando manejimendi system, kuve nechokwadi chekuti zvigadzirwa zvemhando yepamusoro zvinoshandira vatengi pasi rese.Yakakura zvishoma nezvishoma kuita bhizinesi rine mukurumbira pasi rose rakakura uye repakati-yepamusoro-tekinoroji inoshanda muR&D, kugadzira, kutengesa uye sevhisi ye in vitro yekukurumidza diagnostic reagents.
Nguva yekutumira: Oct-28-2021
