PRODUCT EVALUATION STATUS ANTIBODY TEST KITS

Updated as of March 08, 2021

A. Rapid Test Kits
A. Rapid Test Kits
No.Product NameManufacturerSTATUS
1SARS-CoV-2 Antibody Test (COLLOIDAL GOLD IMMUNOCHROMATOGRAPHY)Beijing Lepu Medical Technology Co., Ltd.ON-GOING -
Product Samples Received
2SARS-COV-2 IgGM/IgG Antibody Assay Kit (Colloidal Gold Method)Zybio, Inc.ON-GOING -
Product Samples Received
3COVID-19 IgG/IgM Rapid Test CassetteHangzhou Biotest Biotech Co., Ltd.ON-GOING -
Product Samples Received
42019-nCOV/COVID-19 IgG/IgM Rapid Test DeviceHangzhou Realy Tech Co., Ltd.ON-GOING -
Product Samples Received
5NADAL COVID-19 IgG/IgM TestNAL VON MINDEN GmbhON-GOING -
Product Samples Received
62019 n-CoV IgG/IgM RAPID TEST CASSETTEHangzhou Alltest Biotech Co., Ltd.ON-GOING -
Product Samples Received
7SARS-CoV2(COVID-19) IgG/IgM Antibody Test (Colloidal Gold)Hangzhou Testsea Biotechnology Co., Ltd.ON-GOING -
Product Samples Received
8COVID-19 IgG/IgM RAPID TEST CASSETTEHealgen Scientific LimitedON-GOING -
Product Samples Received
9COVID-19 IgM Antibody Rapid Test KitHecin Scientific, Inc.ON-GOING -
Product Samples Received
10SARS-CoV-2 IgG/IgM Rapid TestZhuhai Encode Medical Engineering Co., Ltd.ON-GOING -
Product Samples Received
112019-nCoV IgG/IgM Rapid TestDynamiker Biotechnology (Tianjin) Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
12GenBody COVID-19 IgG/IgM RAPID DIAGNOSTIC TESTGenbody Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
13Novel Coronavirus (2019nCoV) IgG/IgM Test Kit (Colloidal Gold)Genrui Biotech Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
14COVID-19 IgG/IgM RAPID TEST CASSETTEZhejiang Orient Gene Biotech Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
15QuickProfile COVID-19 IgG/IgM Combo Test CardLumiquick Diagnostics Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
16LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)Hangzhou Laihe Biotech Co Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
17Diagnostic Kit for SARS-CoV-2 IgM/IgG Antibody (Colloidal Gold)Shanghai Kehua Bio-Engineering Co., LtdPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
18COVID-19 IgG/IgM RAPID TEST DEVICEInnovation Scientific Pty LtdPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
19STANDARD Q COVID-19 IgM/IgG COMBO TESTSD Biosensor Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
20COVID-19 IgG/IgM Rapid Test CassetteChil Tibbi Mal. San. Tic. Ltd. Şti.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
21PCL COVID19 IgG/IgM Rapid GoldPCL, Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
22SGTi-flex COVID-19 IgM/IgGSugentech Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
23Biohit SARS-CoV-2 IgM/IgG Antibody Test KitBiohit Healthcare (Hefei) Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
24ACON SARS-CoV-2 IgG/IgM Rapid TestAcon Biotech (Hangzhou) Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
25SMART COVID-19 IgM-IgG RDTCell Id Pte LtdPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
26SARS-CoV-2 IgG/IgM KitGoldsite Diagnostics Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
27SuperFlex Anti-SARS-CoV-2 Ab/IgM/IgGSuzhou Sym-Bio Lifescience Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
28COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test KitWuhan Easydiagnosis Biomedicine Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
29Anti-SARS-CoV-2 Rapid TestB-Bio, Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
30Humasis COVID-19 IgG/IgM Antibody TestHumasis Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
31COVID-19 IgG/IgM Rapid Test KitNantong Egens Biotechnology Co LtdPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
32Novel Coronavirus(2019-nCoV) Antibody (IgG/IgM) Combined Test Kit (Immunochromatographic method)Shenzhen Landwind Biotechnology Co., LtdPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
33COVID-19 IgM/IgG Antibody TestArtron Laboratories Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
34Aria COVID-19 IgG/IgM Rapid TestCTK Biotech Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
35FREND COVID-19 total AbNanoentek, Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
36SARS-CoV-2 IgM Reagent kitAbbot Ireland Diagnostics DivisionPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
37SARS-CoV-2 IgG ScreenImbian Lab Llc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
B. Enzyme Immunoassays (EIAs) | B.1. Flourescene Immunoassay | B.2. Enzyme Linked Flourescent Assay
B. Enzyme Immunoassays (EIAs)
NoProduct NameManufacturerSTATUS
1COVID-19 IgM/IgG ConfirmationDia.Pro Diagnostic Bioprobes S.R.LON-GOING -
Product Samples Received
2COVID-19 (SARS-CoV-2) IgA, IgM, IgG ELISADemeditec Diagnostics GmbhPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
3GA CoV-2 IgG, IgM, IgG+GA Generic Assays GmbhPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
4COVID-19 IgM/IgG Antibody ELISA Test KitBeijing Kewei Clinical Diagnostic Reagent Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
5ENZY-WELL SARS-CoV-2 IgA/IgM/IgGDiesse Diagnostica Senese S.P.A.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
6GenScript SARS-CoV-2 Neutralization Antibody Detection KitGenscript Biotech (Singapore) Pte LtdPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
7SCoV-2 Detect IgG/IgM ELISAInbios International Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
8Kit for the detection of class G immunoglobulins (IgG) to the SARS-CoV-2 coronavirus by the enzyme immunoassay "SARS-CoV-2-IgG-ELISA"Allel LlcPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
B.1. Flourescene Immunoassay
NoProduct NameManufacturerSTATUS
1AFIAS COVID-19 AbBoditech Med Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
2ichroma™ COVID-19 AbBoditech Med Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
B.2. Enzyme Linked Flourescent Assay
NoProduct NameManufacturerSTATUS
1VIDAS® SARS-COV-2 IgM/IgGBiomérieux SaPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
C. Chemiluminescence Immunoassay
C. Chemiluminescence Immunoassay
NoProduct NameManufacturerSTATUS
1Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)Siemens Healthcare Diagnostics Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
2VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgGOrtho-Clinical Diagnostics, Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
3LIAISON® SARS-CoV-2 S1/S2 IgGDiasorin S.P.APENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
4VITROS Anti-SARS-CoV-2 Total AssayOrtho-Clinical Diagnostics, Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
5SARS-CoV-2 IgM/IgG (CLIA)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
6SARS-CoV-2 IgG ASSAY for ALINITY INSTRUMENTAbbott Ireland Diagnostics DivisionPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
7ACCESS SARS-CoV-2 IgG/IgMBeckman Coulter, Inc.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
8SARS-COV-2 IgG/IgM (Electrochemiluminescence Immunoassay)Shenzhen Lifotronic Technology Co., Ltd.PENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
9Diazyme DZ-Lite SARS-CoV-2 IgG/IgM CLIA KitDiazyme Laboratories, IncPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team
10Elecsys Anti-SARS-CoV-2 E2GRoche Diagnostic GmbhPENDING - Schedule of Payment and Submission of Samples to be coordinated by the Kit Evaluation Team