Ibicuruzwa binini byemejwe na FDA byemewe

Vuba aha, ibicuruzwa bitatu bya Bigfish Automatic Nucleic Acid Instrument Instrument ， ADN / RNA Gukuramo / Gusukura Igikoresho hamwe na fluorescence yuzuye ya PCR isesengura isesengura PCR byemejwe nicyemezo cya FDA. Bigfish yongeye kubona icyubahiro ku isi yose nyuma yo kubona icyemezo cy’iburayi CE. Ibi birerekana ibicuruzwa byinjiye mumasoko yo muri Amerika nandi masoko yo hanze.
Icyemezo cya FDA ni iki

FDA isobanura Ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge ， byemewe na USCongress ， aribyo guverinoma ihuriweho na leta, kandi nicyo kigo cyo hejuru cyubahiriza amategeko kabuhariwe mu gucunga ibiryo n'ibiyobyabwenge. Ni urwego rukurikirana ubugenzuzi bw’ubuzima bwa leta, rugizwe n’abaganga, abanyamategeko, abahanga mu binyabuzima, abahanga mu bya shimi n’ibarurishamibare, rugamije kurengera, guteza imbere no guteza imbere ubuzima bw’igihugu. FDA irinda Amerika kwirinda indwara zandura kandi yagize uruhare runini mu kurwanya icyorezo cy’indwara ya Coronavirus (COVID-19). Kubera iyo mpamvu, ibindi bihugu byinshi bishakisha kandi byakira ubufasha bwa FDA mu kuzamura no kugenzura umutekano w’ibicuruzwa byabo.

Ibiranga ibicuruzwa
1. Sisitemu yo kweza aside nucleique （96）
Imiterere ya Bigfish Automatic Nucleic Acide Igikoresho cyububiko gifite igishushanyo mbonera cyiza, cyuzuye ultra-violet sterilisation hamwe nubushyuhe, hamwe na ecran nini yo gukoraho byoroshye gukora. Numufasha mwiza mugushakisha kwa molekuline ivura no gukora ubushakashatsi bwa siyanse ya biologiya.

2.DNA / RNA Gukuramo / Igikoresho cyo kweza
Igikoresho gikoresha uburyo bwa magnetiki bwo gutandukanya no kweza kugirango bikuremo acide nucleic ya virusi zitandukanye za RNA / ADN, nka virusi y’ingurube y’ingurube nyafrica na acide ya nucleique ya Novel Coronavirus, uhereye kuri serumu, plasma na swab soak.Bishobora gukoreshwa muburyo bwo hasi PCR / RT -PCR, ikurikiranye, isesengura rya polymorphism hamwe nubundi bushakashatsi bwa acide nucleic nubushakashatsi. Hamwe nisosiyete yacu yuzuye ya Automatic Nucleic Acide Igikoresho hamwe nibikoresho byabanjirije gupakira, birashobora kuzuza byihuse umubare munini wicyitegererezo cyo gukuramo aside nucleic.

3.Igihe nyacyo Fluorescent Quantitative PCR Isesengura
Isesengura-nyaryo rya fluorescent isesengura PCR ni nto mubunini, byoroshye kandi byoroshye gutwara. Hamwe n'imbaraga nyinshi kandi zihamye zo gusohora ibimenyetso, ifite ecran ya 10.1-yimashini ikora byoroshye gukora. Porogaramu isesengura ni umukoresha-byoroshye kandi byoroshye gukora. Ibikoresho bya elegitoroniki bishyushye birashobora gufunga mu buryo bwikora aho kuba intoki. Guhitamo Internet yibintu module kugirango tumenye kure yubwenge bwo kuzamura imiyoborere izwi neza nisoko.