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

Siyakuhalalisela!!!”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 igunyaziwe ukuthi ithengiswe Imakethe yasePhilippines 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-Tessea ilandela ngokuqinile i-ISO13485 kanye ne-ISO9001 yokusebenza kohlelo lokuphathwa kwekhwalithi ngocwaningo, ukukhiqiza, ukulawulwa kwekhwalithi, ezezimali, ukuthengisa kwasekhaya nokuthengiswa kwamanye amazwe njll. futhi bathole isitifiketi sokuzihlola se-CE 1011/1434. e-EU, isitifiketi se-Therapeutic Goods Administration(TGA) e-Australia, Thailand Food and Drug Administration(FDA) kanye nezinye izitifiketi ezivela emazweni ahlukene, ezibonisa ikhwalithi yemikhiqizo yethu kuvunywe 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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