Izindaba

U-Illumaxbio, umthuthukisi ohamba phambili wobuchwepheshe bokuxilonga ngezokwelapha, uyajabula ukumemezela ukuthi amasistimu ayo amane aguquguqukayo e-CLEIA kanye nama-60 ahambisana ne-single-use chemiluminescence immunoassay reagent kits athole isitifiketi se-CE.Imikhiqizo yakhelwe futhi yaklanywa ukuze inikeze isivinini esingenakuqhathaniswa, ukwethembeka, nokunemba, ehlangabezana namazinga aphezulu wamazwe omhlaba okuphepha nokusebenza kahle.

Izinhlelo ze-CLEIA bezihamba phambili kubuchwepheshe bokuxilongwa kwezokwelapha, ngekhono lazo lokusiza ukuhlonza izimo zezokwelapha ngokucaciswa okuphezulu nokuzwela.Izinhlelo ezithuthukisiwe ze-Illumaxbio ze-CLEIA - i-lumilite8, i-lumilite8s, i-lumiflx16, ne-lumiflx16s - ziqede ukubhaliswa kwe-IVDR CE, okuqinisekisa ukuthi amakhasimende emhlabeni wonke athola kuphela imikhiqizo yekhwalithi ephezulu kakhulu.

Njengoba i-Europe ishintsha isuka ku-IVDD iye ku-IVDR CE imithethonqubo, i-Illumaxbio ibonise ukuzibophezela ekwanelisekeni kwamakhasimende ngokuhambisana nemithetho yakamuva.Ezilungiselelweni zomtholampilo, ukuxilonga nokwelashwa ngokushesha nangokunembile kwezimo zezokwelapha kubalulekile, futhi izinhlelo ezintsha ze-CLEIA ezivela ku-Illumaxbio zingathenjwa ukuthi zinikeze imiphumela esiza odokotela ukuba bahlonze ngokuzayo labo abangase badinge amasu okwelapha anolaka.

Amakhithi angu-60 ahambisana nokusetshenziswa okukodwa kwe-chemiluminescence immunoassay reagent nawo aseqedile ukubhaliswa kwe-IVDD CE, ehlinzeka ngemiphumela esheshayo nesebenziseka kalula yezinhlobonhlobo zezimo zezokwelapha, okuhlanganisainhliziyo, ukuvuvukala, izimpawu zesimila, ukuzala, ukuhlolwa kwangaphambi kokubeletha, kanye nomsebenzi we-thyroid, phakathi abanye.Lawa ma-reagent kits aklanyelwe ukusetshenziswa kanye, okuvumela ukuhlanganiswa kalula ezibhedlela nasemitholampilo, kuthuthukiswe ukugeleza komsebenzi okuphelele kwabasebenzi basemtholampilo.

Njengomholi wezobuchwepheshe bokuxilonga ngezokwelapha, u-Illumaxbio uzoqhubeka nokutshala imali ocwaningweni nasekuthuthukisweni ukuze ahlangabezane nezidingo zamakhasimende emhlabeni jikelele.Umgomo usalokhu uwukuhlinzeka ngezixazululo zokuxilonga okulula ukuzisebenzisa eziletha imiphumela enokwethenjelwa, ekugcineni ziqondise odokotela emasubeni okwelapha asheshayo nanembile eziguli zabo.

I-CEO neThimba Labaphathi be-Illumaxbio bathanda ukuhalalisela ithimba labo lonjiniyela nososayensi abasezingeni lomhlaba ngokuthola isitifiketi se-CE salezi zinhlelo ezintsha nezisindisa ukuphila.Ijubane elingakaze libonwe, ukunemba, nokuthembeka kwalezi zinhlelo nama-reagents kuwubufakazi bokuzinikela, ubuchwepheshe, nokusebenza kanzima kwawo wonke umuntu ohilelekile.