FDA Advisory No. 2020-483 || FDA APPROVES RAPID ANTIBODY TEST KITS FOR COVID-19

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].

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