Ngena kwimarike yase-US - Iimveliso zokufumanisa iziyobisi zeLyher zifumana i-FDA (510k) isatifikethi sobhaliso

245 amagama | Igqityelwe ukuvuselelwa: 2024-01-17 | By UGqr Aaron Chen
Dr. Aaron Chen - author
Umbhali: UGqr Aaron Chen
UGqr Aaron Chen yingcali yenzululwazi yezonyango kunye ne-12 + iminyaka yamava ekuxilongweni kwekliniki kunye ne-POCT. Ukhokela uphando kuvavanyo olukhawulezayo lokuyila, ukuqhuba impumelelo kwi-high-emvandelelo yegolide ye-colloidal kunye novavanyo lwe-immunofluorescence.
Enter the US market | Lyher drug detection products obtain FDA (510k) registration certificate
Isiqulatho
    LYHER® Ikhithi yovavanyo lwe-rinji (thc) (i-thc / i-carsette) kunye ne-lyry® I-Urner Mumine - Uvavanyo lweziyobisi
    Ukusetyenziswa kakubi kweziyobisi kuye kwaba yingxaki yezempilo yoluntu jikelele kunye nengxaki enkulu yentlalo. Ezi mveliso zimbini ze-FDA 510k ezivunyiweyo ezivela kwi-Hangzhou Laihe Biotech Co., Ltd ziqulethe iindidi ezahlukeneyo zendibaniselwano kunye neefom, ezinokuthi zisetyenziswe ngokuguquguqukayo kwiimeko ezahlukeneyo zokuhlola ukusetyenziswa kweziyobisi.
    Umchamo omninzi - Uvavanyo lweKhithi yoVavanyo lweziyobisi kugxininiso kwamanye amachiza axhaphakileyo adweliswe yiU.S. Ulawulo loKhuseleko lwezoThutho kwaye lunokusetyenziselwa ukubhaqwa komgangatho wokuqala we-AMP/OPI/COC/THC/MET/PCP kumchamo. Umchamo wentsangu (THC) Ikhithi yoVavanyo igxile ikakhulu kuvavanyo lomchamo wentsangu eyodwa. Kwiindawo apho intsangu isemthethweni, iimfuno zokuvavanya ngakumbi zinokuvela.

    Ukufunyanwa kwezi zatifikethi zimbini kubonisa ukungena okusemthethweni kweemveliso zovavanyo lweLaihe kwi-I.S.
    I-Laihe iya kuzibophelela ekuziseni iimveliso ezingaphezulu zovavanyo lweziyobisi kwimarike yase-US, iphucule ngakumbi i-matrix yemveliso, iphumeze ngokuthe ngcembe kwaye ikhuthaze ngokuthe ngcembe isicwangciso esisekiweyo, kunye nokuqinisekisa uphuhliso olunzulu, ukucokiswa kunye namandla kwimimandla yesifo esosulelayo kunye novavanyo lweziyobisi.

    Qhagamshelana nathi ukuze ufumane ngakumbi malunga neenkcukacha zemveliso office@lyher.com