Inilabas ng FDA ang inisyal na listahan ng mga aprubadong COVID-19 test kits para sa commercial use.
Kabilang dito ang mga sumusunod:
– Nucleic acid detection kit for 2019 ncov
(Manufacturer: Shanghai GenoeDx Biotech Co., LTD-Shanghai, China)
(Distributor: S&S Enterprises)
– Novel coronavirus 2019-ncov nucleic and detection kit (fluorescence PCR method)
(Manufacturer: Beijing Applied Biological Technologies Co., Ltd-Changing District 102206 Beijing P.R.
(Distribution: Sahar Internation)
– AllplexTM 2019-nCoV Assay
(Manufacturer: Seegene Inc. Seoul, Republic of Korea)
(Distributor: Endure Medical, Inc.)
– SOLGENT DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
(Manufacturer: Solgent Co., Ltd-3F, 32, Techno 6-ro, Yuseong-gu, Daejeon, South Korea)
(Distributor: Wellness Pro Incorporated)
Sinabi ng ahensya na ang mga nasabing kit ay nakapag-comply sa itinakdang requirements batay sa FDA memorandum no. 2020-006 o “Issuance of Special Certification for Imported Test Kits of COVID-19.”
Paalala ng FDA, ireport ang pagbebenta ng mga COVID-19 test kit na hindi kabilang sa listahan sa kanilang online reporting facility na eReport sa www.fda.gov.ph/report o e-mail sa report@fda.gov.ph.