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.
| PRODUCT NAME | MANUFACTURER | |
| 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.
https://drive.google.com/open?id=1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez
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