Imikhiqizo ye-Bigfish igunyazwe yi-FDA eqinisekisiwe

Muva nje, imikhiqizo emithathu ye-Bigfish Automatic Nucleic Acid Purification Instrument, i-DNA/RNA Extraction/Ikhithi Yokuhlanza kanye nesihlaziyi se-PCR esinesikhathi sangempela se-fluorescence sigunyazwe isitifiketi se-FDA. I-Bigfish iphinde yathola ukuqashelwa kweziphathimandla zomhlaba ngemuva kokuthola isitifiketi se-European CE. Lokhu kuphawula ukungena ngokusemthethweni komkhiqizo emakethe yase-US nakwezinye izimakethe zaphesheya kwezilwandle.
Yini isitifiketi se-FDA

I-FDA imele Ukuphathwa Kwezokudla Nezidakamizwa, okugunyazwe yi-USCongress, okunguhulumeni wobumbano, futhi iyisikhungo esiphezulu somthetho esisebenza ngokukhethekile ku-Food and Drug Administration. Futhi iyinhlangano eqaphayo yokulawulwa kwezempilo kahulumeni, eyakhiwe ngodokotela, abameli, izazi ze-microbiology, osokhemisi kanye nezibalo, ezizinikele ekuvikeleni, ekukhuthazeni nasekuthuthukiseni impilo yesizwe. I-FDA ivikela i-United States ezifweni ezithathelwanayo ezivelayo futhi ibambe iqhaza elikhulu ekulawuleni ukuqubuka kwenoveli yesifo iCoronavirus (COVID-19). Ngenxa yalokho, amanye amazwe amaningi afuna futhi athole usizo lwe-FDA ukuze akhuthaze futhi aqaphe ukuphepha kwemikhiqizo yawo.

Izici zomkhiqizo
1.I-Nucleic Acid Purification System (96)
Isakhiwo se-Bigfish Automatic Nucleic Acid Purification Instrument sinomklamo omuhle kakhulu wesakhiwo, umsebenzi ophelele wokuvala inzalo ye-ultra-violet nemisebenzi yokushisisa, enesikrini esikhulu sokuthinta okulula ukusisebenza. Ingumsizi osebenzayo wokutholwa kwamangqamuzana omtholampilo kanye nocwaningo lwesayensi lwesayensi yebhayoloji yamangqamuzana.

2.DNA/RNA Isizinda/Ikhithi Yokuhlanza
Ikhithi isebenzisa ubuchwepheshe obuhlukanisa ubuhlalu obuzibuthe kanye nobuchwepheshe bokuhlanza ukuze kukhishwe ama-nucleic acid amagciwane ahlukahlukene e-RNA/DNA, njenge-African swine fever virus kanye ne-Novel Coronavirus nucleic acid, ku-serum, i-plasma kanye namasampula okucwiliswa kweswab. Ingasetshenziswa ku-PCR/RT engezansi -I-PCR, ukulandelana, ukuhlaziywa kwe-polymorphism nokunye ukuhlaziywa kwe-nucleic acid nokuhlolwa kokutholwa. Nge-Automatic Nucleic Acid Purification Instrument yenkampani yethu ngokugcwele kanye nekhithi yokulayisha ngaphambili, ingaqedela ngokushesha inani elikhulu lamasampula okukhishwa kwe-nucleic acid.

3.Real-time Fluorescent Quantitative PCR Analyzer
I-Real-time fluorescent quantitative PCR analyzer incane ngosayizi, iyaphatheka futhi kulula ukuyihambisa. Ngamandla aphezulu kanye nokuzinza okuphezulu kokuphuma kwesignali, inesikrini sokuthinta esingu-10.1-intshi okulula ukusisebenza. Isofthiwe yokuhlaziya isebenziseka kalula futhi kulula ukuyisebenzisa. Isivalo esishisayo esizenzakalelayo se-elekthronikhi singavala ngokuzenzakalelayo kunokuthi sivaleke mathupha. Imojula ye-inthanethi Yezinto Engakhethwa ukuze uthole ukuphathwa kokuthuthukiswa okukhaliphile okude okuqashelwa kahle yimakethe.