Ukuhlolwa kwe-antigen ye-Testsealabs® COVID-19 kuvunywe yi-Philippine FDA

Halala!!!”I-Testselabs® COVID-19 Antigen Rapid Test” ekhiqizwe i-Testsea ithole Isitifiketi se-FDA e-Philippines ngo-April 25, 2022. Isitifiketi sibonisa ukuthi imikhiqizo ye-Testsealabs® COVID-19 Antigen Rapid Test ivunyelwe ukuthengiswa emakethe yase-Philippines nguhulumeni wasekhaya.

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Umkhiqizo wethu ungasetshenziswa kokubili ukusetshenziswa kochwepheshe kanye nokusetshenziswa ekhaya (ukuzihlola). Kulula ukuthi izikhungo, abantu ngabanye kanye nemindeni zithole amasampula e-nasal/nasopharyngeal/oropharyngeal swab ngokushesha nangesikhathi.

 isizathu sokuduma kwayo:

* Ukucaciswa okuphezulu nokuzwela

* Umphumela osheshayo ngemizuzu eyi-15-20

* Kulula ukuqoqa amasampula* Awekho amathuluzi adingekayo* Imiphumela ibonakala ngokucacile

* Ifanele imiqhele emisha yezinga elikhulu* Thola ukutheleleka kusenesikhathi

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Selokhu kwaqubuka i-COVID-19, i-Testsea ilandela ngokuqinile i-ISO13485 kanye ne-ISO9001 yokusebenza kohlelo lokuphathwa kwekhwalithi ngocwaningo, ukukhiqizwa, ukulawulwa kwekhwalithi, ezezimali, ukuthengisa kwasekhaya kanye nokuthengisa kwamanye amazwe njll. futhi bathole isitifiketi sokuzihlola se-CE 1011/1434 e-EU, i-Therapeutic Goods Administration evela ku-FDA (e-Australia) nezinye izitifiketi ZokuPhathwa Kwezimpahla Zokwelapha (e-Australia, i-FDA) nokunye Ukuphathwa Kwezidakamizwa amazwe ahlukene, akhombisa izinga lemikhiqizo yethu agunyazwe izikhungo zikahulumeni ezihlobene. Futhi, imikhiqizo yethu inegama elihle kanye nomthelela womkhiqizo ovela ezimakethe zaphesheya kwezilwandle. I-Tessea izoqhubeka nokucwaninga nokuthuthukisa imikhiqizo yokuhlola esheshayo ye-COVID-19 futhi ifake isandla ekulweni nobhubhane lwe-COVID-19 emhlabeni jikelele.

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Isikhathi sokuthumela: Apr-29-2022

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