I-A101 yethu ye-a101 sele ifumene imvume ye-IVDR.
Ngoku ibuyiselwe kwimarike yaseYurophu.Sinalo nesatifikethi sekhithi yethu ngokukhawuleza.
Umgaqo we-A101 ANALLERER:
1. Imowudi yokujonga edibeneyo edityanisiweyo, indlela yokuguqula ifoto yoCwangciso kunye nendlela yokuhlola, i-wiz Inkqubo yohlalutyo inokusetyenziselwa ukufaneleka kunye nobungakanani.
2.Wiz - Inkqubo yohlalutyo ilungele iindlela ezahlukeneyo zokuvavanywa ezifana negolide, i-Latex kunye nohlalutyo lwe-fluorescence.
3.I-3.it ilungele iisampulu zokuchonga ezahlukeneyo (igazi liphela, iplasma, i-serum okanye umchamo njlnjl.) Kwaye yiqonga lokufumana kunye neqonga lohlalutyo.
4.Amenzi wepatent yenzelwe ukuba ihambelane nexesha lokufumanisa okwahlukileyo kunye nokuqonda ukuphononongwa ngokuqhubekayo.
Inqaku:
I-1.High imvakalelo
Okungasebenziyo, kulungelelene, ilungele isibhedlele sasekuhlaleni, i-PACT, isebe lekliniki, iKlinikisi, inkonzo engxamisekileyo, isebe elingxamisekileyo, njl
3.Comication yemigaqo-siseko eyahlukeneyo yovavanyo kunye neeprojekthi (igolide yeColodal, i-Latex kunye neFleorescence)
4.Cofatatisobi yezinto ezahlukeneyo zovavanyo, iindidi ezahlukeneyo zesampulu (igazi liphela, iplasma okanye umchamo) kunye namaxesha ahlukeneyo okufumanisa
5. Chaza umgangatho wokutolika kwaye uphephe impazamo yamehlo
6. Inqanaba lemigangatho emithathu yokufumana inyathelo, ulwazi lwesampulu kunye nesiphumo sovavanyo dibanisa enye, qhagamshela inkqubo yenkqubo, isiphumo sokulayisha ngokuzenzekelayo
Nxibelelana nabo ukuba unemidla ye-wih yethuA101 Uhlalutyo. Ulwazi oluthe kratya, i-Pls ziyaqhagamshelana nathi nangaliphi na ixesha.
IXESHA LOKUQALA: UNv-09-2022