Umhlalutyi wethu we-A101 sele efumene imvume ye-IVDR.

Ngoku yamkelwa yi-Europeanm market.Sikwanaso nesatifikethi se-CE kwikhithi yethu yovavanyo olukhawulezayo.

Umgaqo we-A101 analzyer:

I-1.Ngendlela yokufumanisa edibeneyo edibeneyo, umgaqo wokufumanisa ukuguqulwa kwe-photoelectric kunye nendlela ye-immunoassay, inkqubo ye-WIZ A yokuhlalutya ingasetyenziselwa ukufumanisa umgangatho kunye nobuninzi.

I-2.WIZ-Inkqubo yokuhlalutya ifanelekile kwiindlela zokuvavanya ezahlukeneyo ezifana negolide ye-colloidal, i-latex kunye nohlalutyo lwe-fluorescence.

I-3.Ifanelekile kwiisampuli zokubona ezahlukeneyo (igazi elipheleleyo, i-plasma, i-serum okanye umchamo njl.) kwaye iyindawo ehambelanayo yokufumanisa kunye nokuhlalutya.

4.Isakhiwo selungelo elilodwa lomenzi wechiza siyilelwe ukuba sihambelane nexesha elahlukileyo lokubhaqa kunye nokuqaphela ubhaqo oluqhubekayo .

Uphawu:

1.uvakalelo oluphezulu

2.ephathekayo, elungele isibhedlele soLuntu, i-POCT, isebe leKlinikhi, likaxakeka, ikliniki, inkonzo kaxakeka, i-ICU, iSebe labaLalela ngaphandle, njl.

3.Ukuhambelana kwemigaqo yovavanyo eyahlukeneyo kunye neeprojekthi (igolide ye-colloidal, i-latex kunye ne-fluorescence)

4.Ukuhambelana kwezinto zovavanyo ezahlukeneyo, iintlobo zeesampulu ezahlukeneyo (igazi elipheleleyo, iplasma okanye umchamo) kunye namaxesha ahlukeneyo okubona

5.dibanisa umgangatho wokutolika kwaye uphephe impazamo yamehlo

6.Inkqubo yokukhangela amanyathelo amathathu, ulwazi lwesampulu kunye nesiphumo sovavanyo sihambelana nganye nganye, qhagamshela ngokuzenzekelayo inkqubo ye-LIS, isiphumo silayisha ngokuzenzekelayo.

Nceda uqhagamshelane nathi ukuba unomdla kunye nathiUmhlalutyi we-A101.Ulwazi oluninzi oludingayo, pls ngobubele uqhagamshelane nathi nangaliphi na ixesha.