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
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
NO. 8
9
10
PRODUCT NAME
MANUFACTURER
OnSite COVID-19 IgG/IgM Rapid Test
CTK Biotech, Inc. – 13855 Stowe Dr. Poway California, USA
HIGHTOP SARS-CoV-2 IgM/IgG ANTIBODY RAPID TEST
Qingdao Hightop Biotech Co., Ltd. – No. 369 Hedong Road, Hi-tech Industrial Development Zone, 266112 Qingdao, Shandong, Peoples Republic of China
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test
Cellex, Inc., – 76 TW Alexander Drive, Research Triangle Park, Durham NC 27709-0002, USA
COVID-19 IgG/IgM RAPID TEST KIT
Hangzhou Biotest Biotech Co., Ltd. – 17# Futai Road Zhongtai Street, Yuhang District, Hangzhou, People’s Republic of China
11
12
13
DIAGNOSTIC KIT FOR NOVEL CORONAVIRUS (2019-nCoV) IgM ANTIBODY (MAGNETIC PARTICLE CLIA)
Bioscience (Chongqing) Diagnostic Technology Co., Ltd – 2-4/F Building 2, No.5 Gangcheng Donghuan Road, Jiangbei District, Chongqing, China
DIAGNOSTIC KIT FOR NOVEL CORONAVIRUS (2019-nCoV) IgG ANTIBODY (MAGNETIC PARTICLE CLIA)
Bioscience (Chongqing) Diagnostic Technology Co., Ltd – 2-4/F Building 2, No.5 Gangcheng Donghuan Road, Jiangbei District, Chongqing, China
COVID-19 IgG/IgM Rapid Test Cassette
Healgen Scientific Limited – Liability Company 3818 Fuqua Street Houston, TX 77047, USA
COVID-19 IgG/IgM RAPID TEST CASSETTE
Zhejiang Orient Gene Biotech Co., Ltd – 3787#, East Yangguang Avenue, Dipu Street Anji, Huzhou, 313300, P.R China
BIOLIDICS 2019-nCoV IgG/IgM DETECTION KIT
Biolidics Limited. – 37 Jalan Pemimpin, #02-07, Mapex, Singapore
14
15
16
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
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
NO.
PRODUCT NAME
MANUFACTURER
17
MAGLUMI 2019-nCoV IgM (CLIA)
Shenzhen New Industries Biomedical Engineering Co., Ltd. – No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R. China
18
MAGLUMI 2019-nCoV IgG (CLIA)
Shenzhen New Industries Biomedical Engineering Co., Ltd. – No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R. China
19
Camtech COVID-19 IgM/IgG (CAMTECH-LFART)
Camtech Biomedical Pte Ltd- 217 Henderson Road, #03-08, Singapore
20
VivaDiag™ COVID-19 IgM/IgG Rapid Test
Vivachek Biotech Hangzhou Co. Ltd. - Level 2, Block 2, 146 East Chaofeng Rd., Yuhang Economy Development Zone, Hangzhou, 311100, Zhejiang China
21
Novel Coronavirus (2019-nCoV) Antibody Test Kit (Colloidal Gold)
Shanghai Outdo Biotech Co., Ltd – 3F Building 2, 3F Building 4, 3F Building 5, No. 151 Libing Rd., Pilot Free Trade Zone, 201203 Shanghai, People’s Republic of China
22
DPP COVID-19 IgM/IgG System
Chembio Diagnostic Systems, Inc. - 3661 Horseblock Road Medford, NY 11763 USA
23
Abbott Panbio™ COVID-19 lgG/lgM RAPID TEST DEVICE
Abbott Rapid Diagnostics Jena GmbH – Orlaweg 1 07743 Jena, Germany
24
SARS-CoV-2 Antibody Test (COLLOIDAL GOLD IMMUNOCHROMATOGRAPHY)
Beijing Lepu Medical Technology Co., Ltd – 3th Floor and 5th Floor Building 7-1 No.37 Chaoqian Road, Changping District, Beijing, 102200, P.R. China
25
SARS-CoV-2 IgG ASSAY
Abbott Ireland- Diagnostics Division, Finisklin Business Park, Sligo, Ireland
26
LIAISON® SARS-CoV-2 S1/S2 IgG
Diasorin S.p.A-Via Crescentino SNC, 13040 Saluggia (VC) - Italy
27
COVID-19 IgM Antibody Rapid Test Kit
Hecin Scientific, Inc. – 4F Building A, #1 Ruifa Road, Luogang District, Guangzhou, 510700 P.R 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
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
NO.
PRODUCT NAME
MANUFACTURER
28
Elecsys Anti-SARS-CoV-2 (200 tests, for Roche Diagnostics GmbH, -Sandhofer Strasse 116, Duse in cobas e 411, e 601, e 602) MAT 68305 Mannheim, Germany CODE: 09203095190
29
"Elecsys Anti-SARS-CoV-2 (300 tests, for use in cobas e 801) Mat Code: 09203079190"
Roche Diagnostics GmbH, -Sandhofer Strasse 116, D68305 Mannheim, Germany
30
Diagnostic Kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold)
Shanghai Kehua Bio-engineering Co., Ltd – 1189 North Qinzhou Road, Xuhui District, Shanghai, 200233, People’s Republic of China
31
DiagnoSure COVID-19 IgG/ IgM Rapid Test Cassette
Hangzhou Biotest Biotech Co., Ltd – #17, Futai Road, Zhongtai Street, Yuhang District, 311121 Hangzhou, People’s Republic of China
32
VITROS IMMUNODIAGNOSTIC PRODUCTS Anti-SARS-CoV-2 TOTAL REAGENT PACK USED IN COMBINATION WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS Anti-SARS-CoV-2 TOTAL CALIBRATOR
Ortho-Clinical Diagnostics, Inc.-100 Indigo Creek Drive-Rochester, NY 14626, USA
33
CORONAVIRUS DISEASE 2019 ANTIBODY (IgM/IgG) RAPID TEST CASSETTE
MedicalSystem Biotechnology Co., Ltd.- No. 289, Qiming South Road, Yinzhou District, 315104 Ningbo, China
34
CLONGENE COVID-19 IgG/IgM RAPID TEST CASSETTE
Hangzhou Clongene Biotech Co Ltd. – No 1 Yichuang Road Yuhang Sub district Yuhang District, Hangzhou, 311121 China
35
Anti-SARS-CoV-2 Rapid Test
Autobio Diagnostics Co., Ltd – No. 87, Jingbei Yi Rd, National Eco &Tech Zone, Zheng zhou, China
36
Platelia SARS-CoV-2 Total Ab assay
Bio-Rad Laboratories -3, boulevard Raymond Poincaré 92430 Marnes-la-Coquette - France
37
SARS-COV-2 IgGM/IgG ANTIBODY ASSAY KIT (COLLOIDAL GOLD METHOD)
Zybio, Inc. – Floor 1 to Floor 4, Building 30, No.6 of Taikang Road, Block C of Jianqiao Industrial Park, Dadukou District, 400082 Chongqing, 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
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
NO.
PRODUCT NAME
MANUFACTURER
38
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
Ortho-Clinical Diagnostics- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
39
QuickProfile COVID-19 IgG/IgM Combo Test Card
LumiQuick Diagnostic, Inc.– 2946 Scott Blvd. Santa Clara, USA
40
SARS-CoV2(COVID-19) IgG/IgM Antibody Test (Colloidal Gold)
HangZhou Testsea biotechnology Co.,Ltd– Building 6 No.8-2 Scien-tech Road , Yuhang Street Hangzhou 311121,China
41
GenBody COVID-19 IgG/IgM RAPID DIAGNOSTIC TEST
Genbody Inc.- GenBody Building, 3-18, Eopseong 2gil, Seobuk-gu, Cheonan-si, Chungnam, 31077, Korea
42
2019-nCOV/COVID-19 IgG/IgM Rapid Test Device
Hangzhou Realy Tech Co., Ltd.- 4th floor, #12 Building, Eastern Medicine Town, Xiasha Economic & Technological Development Area, 310018 Hangzhou, Zhejiang, People’s Republic of China
PCL COVID19 IgG/IgM RAPID GOLD
PCL, Inc. – # 701, 99, Digital-ro 9-gil, Geumcheon-gu, Seoul, 08510, Republic of Korea
ORIGHT COVID-19 IgG/IgM RAPID TEST KIT
Hangzhou Biotest Biotech Co., Ltd. – 17# Futai Road Zhongtai Street, Yuhang District, Hangzhou, People’s Republic of China
LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Hangzhou Laihe Biotech Co Ltd. – Floor 1 Room 505-512 Floor, 5 Building B 688 Bin'an Road, Binjiang District, Hangzhou, 310052, China
COVID-19 IgG/IgM RAPID TEST DEVICE
Innovation Science Pty Ltd – 5/25 Stoddart Rd, Prospect, NSW, 2148, Australia
ORIGHT COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Hangzhou Biotest Biotech Co.,Ltd- #17, Futai Road,Zhongtai Street, Yuhang District, 311121 Hangzhou, P.R.China
NANJING VAZYME 2019-nCoV IgG/IgM DETECTION KIT
Nanjing Vazyme Medical Technology Co., Ltd – Level 1-3, Bldg. C2, Red Maple Sci-Tech Park, Kechuang Road, Nanjing China
43 44
45
46 47
48
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
Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION
COVID-19 IgG CONFIRMATION
Dia.Pro Diagnostic Bioprobes S.r.l.-Via G. Carducci n° 27 – Sesto San Giovanni (MI) – Italy
COVID-19 IgA
Dia.Pro Diagnostic Bioprobes S.r.l.-Via G. Carducci n° 27 – Sesto San Giovanni (MI) – Italy
COVID-19 IgG
Dia.Pro Diagnostic Bioprobes S.r.l.-Via G. Carducci n° 27 – Sesto San Giovanni (MI) – Italy
COVID-19 IgM
Dia.Pro Diagnostic Bioprobes S.r.l.-Via G. Carducci n° 27 – Sesto San Giovanni (MI) – Italy
49 50 51 52 53
ichroma COVID-19 Ab
Boditech Med Incorporated- 43, Geodudanji 1-gil, Dongnae-myeon,- Chuncheon-si, Gang-won-do, 24398Republic of Korea
54
AFIAS COVID-19 Ab
Boditech Med Incorporated- 43, Geodudanji 1-gil, Dongnae-myeon,- Chuncheon-si, Gang-won-do, 24398Republic of Korea
55
SARS-CoV-2 IgG ASSAY FOR ALINITY INSTRUMENT
Abbott Ireland- Diagnostics Division, Finisklin Business Park, Sligo, Ireland
56
SAR-CoV-2 IgG/IgM Rapid Test
Zhuhai Encode Medical Engineering Co., Ltd – No. 20, Honghui 2nd Road, Hongqi Industrial Zone, Jinwan District, Zhuhai, China
56
COVID-19 IgG/IgM Rapid Test Cassette
CHIL TIBBİ MAL. SAN. TİC. LTD. ŞTİ. -10028 sok. No.11 AOSB 35620 Cigli-Izmir/Turkey
58
SARS-CoV-2 IgG (CLIA)
Shenzhen Mindray Bio-Medical Electronics Co-Ltd– Mindray Building Keji l2th Road South, Hitech Industrial Park, Nanshan, Shenzhen, People’s Republic China
59
SARS-CoV-2 IgM (CLIA)
Shenzhen Mindray Bio-Medical Electronics Co-Ltd– Mindray Building Keji l2th Road South, Hitech Industrial Park, Nanshan, Shenzhen, People’s Republic China
* Updated list in yellow highlights
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