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izindaba

I-MHRA, i-Medicines and Healthcare products Regulatory Agency ilawula imithi, amadivayisi wezokwelapha nezakhi zegazi zokumpontshelwa e-UK.

UMnyango Wezempilo Nokunakekelwa Komphakathi (i-DHSC) ukhiphe ifayili le- iphepha lenqubomgomo mayelana nokwanda kwezinhlelo zokuhlola ze-coronavirus (COVID-19).

I-MHRA isebenza nabalingani ukuxhasa ukulethwa kohlelo lukahulumeni ekuhlolweni kwe-COVID-19.

Ngemuva kokuqubuka kweCovid-19 kanye nesidingo esikhula ngokushesha sokuhlinzeka ngezinsizakalo nemishini ephuthumayo, uGenesise uthole isitifiketi se-MHRA ngoMeyi, 2021, njengamanje kumahhala ukuthengiswa emakethe yase-UK.
COVID-19
IGenesis COVID-19 Antigen test kit (Isivivinyo sokusetshenziswa kobungcweti)
Isivivinyo okuhloswe ngaso ukuthi sisetshenziswe ngumsebenzisi ochwepheshe (bheka ngezansi).
Ukuhlolwa kufanele kumakwe i-UKCA noma i-CE kumakwe njenge- “IVD ejwayelekile” ngokuya nge-UK MDR 2002 (njengoba ichitshiyelwe).
Umenzi wesivivinyo kumele akhombise ukuthi babambe ubufakazi bokusekela ukusetshenziswa okuhlosiwe njengoba kushiwo kumiyalo yabo yokusetshenziswa (IFU) isib. isimo, i-IFU kufanele ikwenze kucace lokhu futhi kufanele kube nobufakazi bemininingwane yokusebenza ukusekela ukusetshenziswa kwabo kulezi zimo.


Isikhathi Iposi: Aug-16-2021