Documente Academic
Documente Profesional
Documente Cultură
Department of Health
FOOD AND DRUG ADMINISTRATION
3 DIAGNOSTIC KIT FOR IgM/IgG Zhuhai Livzon Diagnostic Inc. – 1st Building, No. 266,
ANTIBODY TO CORONAVIRUS Tongchang Road, Xiangzhou District, Zhuhai,
(SARS-CoV-2) (COLLOIDAL GOLD) Guangdong Province, People’s Republic of China
6 WANTAI SARS- CoV Ab RAPID TEST Beijing Wantai Biological Pharmacy Enterprise Co.,
KIT Ltd. – 31 Kexueyuan Road, Changping District
Beijing, People’s Republic of China
16
BIOLIDICS 2019-nCoV IgG/IgM Biolidics Limited. – 37 Jalan Pemimpin, #02-07,
DETECTION KIT Mapex, Singapore
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 Biomedical Pte Ltd- 217 Henderson Road,
(CAMTECH-LFART) #03-08, Singapore
20 VivaDiag™ COVID-19 IgM/IgG Rapid Vivachek Biotech Hangzhou Co. Ltd. - Level 2, Block
Test 2, 146 East Chaofeng Rd., Yuhang Economy
Development Zone, Hangzhou, 311100, Zhejiang
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 Abbott Rapid Diagnostics Jena GmbH – Orlaweg 1
RAPID TEST DEVICE 07743 Jena, Germany
24 SARS-CoV-2 Antibody Test Beijing Lepu Medical Technology Co., Ltd – 3th Floor
(COLLOIDAL GOLD and 5th Floor Building 7-1 No.37 Chaoqian Road,
IMMUNOCHROMATOGRAPHY) Changping District, Beijing, 102200, P.R. China
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
28 Elecsys Anti-SARS-CoV-2 (200 tests, for Roche Diagnostics GmbH, -Sandhofer Strasse 116, D-
use in cobas e 411, e 601, e 602) MAT 68305 Mannheim, Germany
CODE: 09203095190
29 "Elecsys Anti-SARS-CoV-2 (300 tests, Roche Diagnostics GmbH, -Sandhofer Strasse 116, D-
for use in cobas e 801) Mat Code: 68305 Mannheim, Germany
09203079190"
30 Diagnostic Kit for SARS-CoV-2 Shanghai Kehua Bio-engineering Co., Ltd – 1189
IgM/IgG Antibody (Colloidal Gold) North Qinzhou Road, Xuhui District, Shanghai,
200233, People’s Republic of China
31 DiagnoSure COVID-19 IgG/ IgM Rapid Hangzhou Biotest Biotech Co., Ltd – #17, Futai Road,
Test Cassette Zhongtai Street, Yuhang District, 311121 Hangzhou,
People’s Republic of 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 Zybio, Inc. – Floor 1 to Floor 4, Building 30, No.6 of
ASSAY KIT (COLLOIDAL GOLD Taikang Road, Block C of Jianqiao Industrial Park,
METHOD) Dadukou District, 400082 Chongqing, China
39 QuickProfile COVID-19 IgG/IgM LumiQuick Diagnostic, Inc.– 2946 Scott Blvd. Santa
Combo Test Card Clara, USA
41 GenBody COVID-19 IgG/IgM RAPID Genbody Inc.- GenBody Building, 3-18, Eopseong 2-
DIAGNOSTIC TEST gil, Seobuk-gu, Cheonan-si, Chungnam, 31077, Korea
42 2019-nCOV/COVID-19 IgG/IgM Rapid Test Hangzhou Realy Tech Co., Ltd.- 4th floor, #12 Building,
Device Eastern Medicine Town, Xiasha Economic & Technological
Development Area, 310018 Hangzhou, Zhejiang, People’s
Republic of China