I-CE igunyaze ikhithi yokuhlola ye-Medical Device Strep A Test

Ukunemba

Ithebula: I-Strep A AntigenRapid Test vs. PCR Test

Ukuzwela Okuhlobene: 94.4% (88.3% -97.9%)*
Ukucaciswa Okuhlobene: 98.2% (96.3% -99.3%)*
Ukunemba: 97.4% (95.5% -98.6%)*
* 95% Izikhawu Zokuzethemba

UKUSETSHENZISWA OKUHLOSIWE

I-Strep A Antigen Rapid Test iyi-assay ye-chromatographic esheshayo yokutholwa kwekhwalithi ye-Strep A antigen kusuka ezihlotsheni ze-swab zomphimbo ukusiza ekuxilongweni kwe-Group A Streptococcal infection.

Inzuzo Yenkampani

1.Eyaziwa njengebhizinisi lobuchwepheshe obuphezulu eShayina, inani lezicelo zamalungelo obunikazi kanye namalungelo okushicilela esoftware avunyiwe.
2.Letha izimpahla njengesicelo se-oda
3.ISO13485, CE, Lungiselela imibhalo ehlukahlukene yokuthumela
4.Phendula imibuzo yamakhasimende phakathi namahora angama-24