FDA approves COVID-19 test kits from China, South Korea

March 19, 2020

The Food and Drug Administration (FDA) said Thursday it approvedf four coronavirus disease 2019 (COVID-19) test kits from China and South Korea.

In a statement, FDA Director General Eric Domingo said they have  released an initial list of approved kits after they have complied with the requirements as stated in the FDA Memorandum No. 2020006.

"FDA has released an initial list of approved kits with Special Certification. There are still pending applications that are due for evaluation," said Domingo.

The two test kits from China are "Nucleic acid detection kit for 2019 ncov" manufactured by Shanghai Connex Biotech Co.; and "Novel coronavirus 2019 ncov nucleic acid detection kit (fluorescence PCR method)" manufactured by Beijing Applied Biological Technologies Co.

The two test kits from South Korea are "AllplexTM 2019-nCoV Assay" manufactured by Seegene Inc.; and "SOLGENT DiaplexQ Novel Coronavirus (2019 nCoV) Detection Kit" manufactured by Solgent Co.

"These are PCR based reagent kits used in laboratories and not point-of care or do-it-yourself kits," noted Domingo. DMS