Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
List of COVID-19 Serologic Test Kits (Rapid, Immunoassays) as of 22 MAY 2020, 5:00PM NO.
PRODUCT NAME
MANUFACTURER
1
NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT
Biolidics Limited. – 37 Jalan Pemimpin, #02-07, Mapex, Singapore
2
NOVEL CORONAVIRUS (2019NCOV) 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
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
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
6
WANTAI SARS- CoV Ab RAPID TEST KIT
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. – 31 Kexueyuan Road, Changping District Beijing, People’s Republic of China
7
2019 n-CoV IgG/IgM RAPID TEST CASSETTE
3
4
Hangzhou Alltest Biotech Co., Ltd. – #550, Yinhai Street, Hangzhou Economy and Technology Development Area, 310018, Hangzhou, People’s Republic of China
Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines Trunk Line +63 2 857 1900 Website: www.fda.gov.ph
Fax +63 2 807 0751 Email: info@fda.gov.ph