Aplikasyon ng 11 manufacturers ng home antigen test kits inihain sa FDA- DOH

Aplikasyon ng 11 manufacturers ng home antigen test kits inihain sa FDA- DOH

January 18, 2022 @ 6:36 PM 7 months ago


MANILA, Philippines- Nakapaghain na ng aplikasyon ang 11 manufacturers ng self-administered antigen test kits sa Food and Drug Administration (FDA), base sa Department of Health (DOH) nitong Martes.

“Meron na pong nag apply sa Food and Drug Administration ng mga home administered kits. Ito po ay mga manufacturers, 11 na po ang nakapag apply,” ani Health Undersecretary Maria Rosario Vergeire sa isang media briefing.

Sinabi ni Vergeire na susuriin pa ng FDA ang antigen test kits bago ito ipadala sa Research Institute for Tropical Medicine para sa performance validation.

“Usually based on the load of work ng RITM, although they were instructed to prioritize this, it will take them about two days no, or 48 hours for them to finish a performance validation for a specific kit,” ani Vergeire.

“Sabihin po natin that within seven to ten days lalabas ang registration o certification nitong mga home administered test kits na napapasa sa standards ng RITM at saka ng FDA,” patuloy pa niya. RNT/SA