Tsis ntev los no, Nanjing LimingBio's Novel Coronavirus (SARS-CoV-2) antigen detection reagent "StrongStep® SARS-CoV-2 Antigen Rapid Test" tau txais kev kuaj xyuas kev ua tau zoo ntawm Paul-Ehrlich-Institut (PEI*) hauv Tebchaws Yelemees, cov khoom no tau raug tau ntawv pov thawj los ntawm German Federal Agency for Medicines and Medical Device Administration (BfArM).LimingBio tau dhau los ua ib qho ntawm ob peb lub tuam txhab hauv Suav teb uas tau txais daim ntawv pov thawj dual ntawm BfArM + PEI hauv Tebchaws Yelemees.Liming Bio's antigen ceev kuaj tau dhau daim ntawv pov thawj ntawm Ministry of Health ntawm ntau lub teb chaws, uas ua pov thawj qhov ua tau zoo ntawm cov khoom siv.
Liming Bio's antigen ceev kuaj tau ua tiav dhau los ntawm German PEI kev ua haujlwm pov thawj
PS PEI: Paul Ehrlich Institute (German: Paul-Ehrlich-Institut), tseem hu ua German Federal Institute of Vaccines thiab Biomedicine, yog lub chaw tshawb fawb thiab kev tswj hwm kev kho mob ntawm German Federation, tam sim no nyob rau hauv Tsoom Fwv Saib Xyuas Kev Noj Qab Haus Huv (BMG ), muaj kev ywj pheej ntawm kev tshuaj xyuas cov khoom siv roj ntsha, kev soj ntsuam kuaj pom zoo, kev pom zoo cov khoom lag luam thiab kev lag luam, thiab kev tshaj tawm batch.Nyob rau tib lub sijhawm, nws tseem ua haujlwm rau kev tsim kho, hloov kho cov kev cai cuam tshuam, thiabmuabscov lus qhia kev tshawb fawb rau cov koom haum sib txawv, tshwj xeeb tshaj yog qee lub tebchaws European Union, European Union thiab cov pab pawg thoob ntiaj teb.Also, nwsmuabscov tswv yim tshaj lij rau tsoomfwv German, cov koom haum hauv zos thiab cov koom txoos, thiab muabscov ntaub ntawv cuam tshuam rau cov neeg mob thiab cov neeg siv khoom.
Liming Bio's antigen ceev kuaj tau ua tiav dhau daim ntawv pov thawj German BfArM
Lub StrongStep® SARS-CoV-2 Antigen Rapid Test tsim los ntawm Nanjing Liming Bio tau ua tiav tau txais daim ntawv pov thawj European Union CE, Tuam Tshoj National Institute for Food and Drug Control (NIFDC) kev tshuaj xyuas kev tshuaj xyuas, nkag mus rau Rockefeller Foundation daim ntawv pom zoo, thiab Guatemala Daim ntawv pov thawj, Italian Ministry of Health certification, German ntawv pov thawj, Ecuador ntawv pov thawj, Brazil (ANVISA) ntawv pov thawj, Chile ntawv pov thawj, Argentina ntawv pov thawj, Dominica ntawv pov thawj, Guatemala ntawv pov thawj, Singapore HSA ntawv pov thawj, Malaysia (MDA) ntawv pov thawj, Philippines FDA ntawv pov thawj, Indonesia ntawv pov thawj.Nws tau txais kev qhuas hauv kev ntsuam xyuas ywj pheej ntawm British Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tib Neeg (DHSC) thiab (British AAA ntawv pov thawj).
Malaysia MDA Novel Coronavirus Antigen Self-Test Certificate
Nta thiab qhov zoo
01 Yooj yim sampling: tsis yog-invasive qauv sau, qaub ncaug los yog nasopharyngeal swab.
02 Kev tshawb pom sai: tag nrho cov txheej txheem tshawb pom tsuas yog siv sijhawm 15 feeb, thiab cov txiaj ntsig tau pom ncaj qha los ntawm lub qhov muag.
03 Kev ua haujlwm yooj yim: Nws tuaj yeem ua haujlwm yam tsis muaj cov cuab yeej pabcuam thiab tsis muaj kev paub dhau los.
04 Kev ua tau zoo heev: qhov tshwj xeeb yog 99.26%, rhiab heev yog 96.2%, thiab qhov tseeb tag nrho yog 95%.
05 Kev xav tau customization: Tam sim no, lub tuam txhab muaj kev kho mob version, kev ntsuam xyuas tus kheej hauv tsev (xiav + nasopharyngeal swab) version thiab Mini self-test version, thiab lwm yam. Lub thawv ntim thiab cov lus qhia tuaj yeem kho raws li cov neeg siv khoom xav tau.
Cov Khoom Siv Hluav Taws Xob no rau SARS-CoV-2 Antigen Rapid Test (pen type) yog nruab nrog cov cuab yeej tiv thaiv kev nyab xeeb, uas tuaj yeem thaiv cov kab mob zoo hauv cov qauv ua cov tshuaj los ntawm volatilizing rau hauv huab cua, ua paug rau ib puag ncig, thiab tiv thaiv tau zoo. tus neeg teb xov tooj thaum lub sij hawm kuaj pom ntawm SARS-CoV-2 antigen quick test.
Cov xwm txheej thoob ntiaj teb tam sim no tseem hnyav heev.Nrog rau qhov tshwm sim thiab kev sib kis ntawm qhov txawv ntawm tus kab mob Novel Coronavirus, qhov xwm txheej kis tau zoo hauv ntau lub tebchaws thiab cheeb tsam tau rov qab los, thiab kev tiv thaiv thiab kev tswj hwm tau ntsib cov teeb meem loj dua.SARS-CoV-2 Antigen Rapid Test yog nrawm, raug, yooj yim rau kev khiav lag luam, thiab xav tau cov cuab yeej siv tsawg thiab cov neeg ua haujlwm.Nws yog qhov tsim nyog rau kev tshawb nrhiav sai ntawm cov neeg xav tias muaj cov kab mob loj-loj tshiab kab mob tshiab, thiab tshwj xeeb tshaj yog siv tau rau kev kuaj mob sai ntawm cov kab mob sib kis.Nws tuaj yeem siv los ua thawj kab kev tiv thaiv kev tiv thaiv kab mob sib kis, siv rau kev tshawb nrhiav cov kab mob thaum ntxov, pab tiv thaiv kev kis tus kab mob, thiab tswj kev kis tus kab mob.
Nanjing Liming Bio-products Co., Ltd. tau tsim muaj nyob rau hauv 2001. Nws yog ib lub tuam txhab tshuaj lom neeg kuaj mob tshwj xeeb hauv kev tshawb fawb thiab kev tsim kho, tsim khoom thiab muag cov chaw kho mob microbial hauv vitro diagnostic reagents.Nws muaj 20 xyoo ntawm kev ua tau zoo heev thiab tau ua tiav cov txheej txheem zoo, thiab tau txais daim ntawv pov thawj IS013485.Kev tswj hwm ntau lawm ua haujlwm nruj me ntsis raws li kev tswj hwm thoob ntiaj teb, kom ntseeg tau tias cov khoom lag luam zoo pab cov neeg siv khoom thoob plaws ntiaj teb.Nws tau maj mam tsim mus rau hauv lub thoob ntiaj teb renowned loj thiab nruab nrab-qhov loj me high-tech enterprise specializing nyob rau hauv R & D, ntau lawm, kev muag khoom thiab kev pab cuam ntawm in vitro ceev diagnostic reagents.
Post lub sij hawm: Oct-28-2021
