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In line with the ongoing response to the increasing number of COVID-19 cases in the Philippines, the Food and Drug Administration (FDA)- Philippines hereby provides an initial list of approved Rapid Antibody Test Kits.

1. NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT Biolidics Limited. – 37 Jalan Pemimpin, #02-07, Mapex, Singapore
2. NOVEL CORONAVIRUS (2019-NCOV) IgM/IgG ANTIBODY DETECTION KIT (COLLOIDAL GOLD METHOD) Nanjing Vazyme Medical Technology Co., Ltd – Level 1-3, Bldg. C2, Red Maple Sci-Tech Park, Kechuang Road, Nanjing China
3. DIAGNOSTIC KIT FOR IgM/IgG ANTIBODY TO CORONAVIRUS (SARS-CoV-2) (COLLOIDAL GOLD) Zhuhai Livzon Diagnostic Inc. – 1st Building, No. 266, Tongchang Road, Xiangzhou District, Zhuhai, Guangdong Province, People’s Republic of China
4. 2019-nCoV ANTIBODY TEST (COLLOIDAL GOLD) Innovita (Tangshan) Biological Technology Co., Ltd. – No. 699 Juxin Street, High-Tech Industrial Development Zone, Qian’an 064400, Hebei, China
5. SARS-CoV-2 ANTIBODY TEST (LATERAL FLOW METHOD) Guangzhou Wondfo Biotech Co., Ltd. – No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, People’s Republic of China

This list shall be regularly updated. For reference please click the link.

To report any sale or distribution of COVID-19 rapid test kits not included in the list, you may email us at [email protected].

Attachment:->FDA Advisory No.2020-483