Kana zvasvika kumidziyo yerabhoritari, zvakakosha kuziva kuti ndezvipi zvinhu zvinowira pasi pemirairo yemidziyo yekurapa. Mazano ePipette chikamu chakakosha chebasa remurabhoritari, asi ndezvokurapa here?
Zvinoenderana neUS Food and Drug Administration (FDA), mudziyo wekurapa unotsanangurwa semudziyo, mudziyo, muchina, kudyara, kana chimwe chinhu chine hukama chinoshandiswa kuongorora, kurapa, kana kudzivirira chirwere kana chimwe chirwere. Nepo matipi epipette akakosha pabasa rerabhoritari, haana kuitirwa kushandiswa kwekurapa uye saka haakodzeri semidziyo yekurapa.
Zvisinei, izvi hazvirevi kuti mazano epipette haana zvachose. Iyo FDA inoronga matipi epipette semidziyo yemurabhoritari, iyo inodzorwa pasi pemirau yakasiyana pane michina yekurapa. Kunyanya, matipi epipette anoiswa senge in vitro diagnostic zvishandiso (IVD), izwi rinoshandiswa kurondedzera midziyo yemurabhoritari, mareagents, uye masisitimu anoshandiswa kuongorora chirwere.
SeIVD, matipi epipette anofanirwa kusangana nezvinodiwa zvekutonga. Iyo FDA inoda kuti maIVD ave akachengeteka, anoshanda uye ape mhedzisiro chaiyo. Kuti usangane nezvido izvi, matipi epipette anofanirwa kugadzirwa pasi pekuomarara kwemhando yekudzora zviyero uye anofanirwawo kuongororwa kuita basa.
KuSuzhou Ace Biomedical Technology Co., Ltd., isu tinotora kuteedzera zvakanyanya. Mazano edu epipette anogadzirwa zvinoenderana neFDA nhungamiro, kuve nechokwadi kuti vanosangana nemhando yepamusoro uye kuchengetedza zviyero. Isu tinoshandisa chete emhando yepamusoro zvigadzirwa uye tinoshandisa epamberi ekugadzira matekiniki kuti tive nechokwadi chekuti matipi edu epipette anounza huchokwadi uye hunoenderana nezvaunoda lab.
Muchidimbu, kunyangwe matipi epipette asina kuverengerwa semidziyo yekurapa, achiri pasi pezvinodiwa zvekutonga seIVDs. Naizvozvo, zvakakosha kuti usarudze mutengesi akavimbika seSuzhou Ace Biomedical Technology Co., Ltd. inosangana nezvose zvinodiwa zvekutonga kuti uve nechokwadi chekuti basa rako remurabhoritari rakarurama, rakavimbika uye rinoenderana nezvose zvinoenderana neindasitiri zviyero.
Nguva yekutumira: May-24-2023