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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Devices

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677 records found
CE Marking Manufacturer Commercial Name ID Method Target Format Navigate
CE Marking: Yes Manufacturer: Sensing Self Pte., Ltd Commercial: S1 Covid-19 Rapid Antigen Test Kit Device ID: 1493 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sensitest Commercial: Sensitest Joysbio Antigen Rapid Test for Covid-19 Device ID: 1272 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Sensiva Health, LLC Commercial: Sensiva Health React Rapid Antigen Test (Lateral Flow Method) Device ID: 2611 Method: Immunoassay Target: IgG, Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: SG Diagnostics Pte Ltd Commercial: SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) Device ID: 2003 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SG Medical, Inc. Commercial: InstaView COVID-19 Antigen Device ID: 2935 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SGA Medikal Commercial: V-Chek SARS-CoV-2 Ag Rapid Test Kit (Colloidal Gold) Device ID: 1319 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SGA Medikal Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (colloidal gold) Device ID: 1357 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SGA Medikal Commercial: V-Chek SARS-CoV-2 Rapid Ag Test (IFA) Device ID: 1317 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SHANDONG KANGHUA BIOTECHNOLOGY CO., LTD Commercial: SARS-CoV-2 Antigen Rapid Test (Immunochromatography) Device ID: 1366 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shandong ThinkLab Biotechnology Co.,Ltd. Commercial: Coronavirus Ag Rapid Test Cassette (Swab) Device ID: 2154 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd. Commercial: BioGerm SARS-CoV-2 Antigen Self Test Device ID: 3039 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shanghai Chemtron Biotech Co., Ltd. Commercial: Chemtrue® COVID-19 Ag Rapid Test (Colloidal Gold) Device ID: 2313 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shanghai Chemtron Biotech Co., Ltd. Commercial: Chemtrue® COVID-19 (SARs-Cov-2)Antigen Rapid Test Kit (Nasal Swab) Device ID: 2512 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shanghai Chemtron Biotech Co.,Ltd. Commercial: Chemtrue® COVID-19(SARS-CoV-2)Antigen Rapid Test Kit (Nasal Swab) - self-test Device ID: 3080 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shanghai Liangrun Biomedicine Technology Co.,Ltd. Commercial: LionRunTM SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay) Device ID: 2155 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shen Zhen Zi Jian Biotechnology Co., Ltd. Commercial: SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit (Lateral Flow Method) Device ID: 2145 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen AIVD Biotech Inc. Commercial: COVID-19/ FluA/ FluB Antigen Combo Rapid Test Kit (Colloidal Gold Method) Device ID: 3087 Method: Immunoassay Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Shenzhen Aivd Biotechnology Co., LTD. Commercial: SARS-CoV-2 Antigen Detection Kit (Latex Lateral Flow Assay) Device ID: 2834 Method: Other Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd Commercial: Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) Device ID: 365 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd Commercial: Bioeasy 2019-Novel Coronavirus (2019-nCoV) Ag GICA Rapid Test Device ID: 689 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen CAS-Envision Medical Technology Co., Ltd. Commercial: SARS-CoV-2 Antigen Rapid Detection Kit Device ID: 2152 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd. Commercial: COVID-19 Antigen Rapid Test Device ID: 3125 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Huaree Technology Co.,Ltd Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) Device ID: 2812 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Huian Biosci Technology Co., Ltd. Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Device ID: 2414 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Huian Biosci Technology Co., Ltd. Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Device ID: 3356 Method: Immunochromatography Target: Antigen Format: Near POC / POC, Other Go to details
CE Marking: Yes Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd. Commercial: SARS-CoV-2 Antigen Rapid Test (Lateral Flow Assay) Device ID: 2166 Method: Immunochromatography Target: Antigen Format: Lab-based, Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Kingfocus Biomedical Engineering Co., Ltd. Commercial: COVID-19 Antigen Detection Kit(Quantum Dots-Based Immunofluorescence Chromatography) Device ID: 2941 Method: Immunochromatography Target: IgG, IgM, Antigen Format: Automated, Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Kisshealth Biotechnology Co., Ltd Commercial: SARS-CoV-2 Antigen Test Kit (GICA) Device ID: 1813 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd Commercial: SARS-CoV-2 Antigen Rapid Test Kit (Immunofluorescence Assay) Device ID: 2989 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd. Commercial: Green Spring SARS-CoV-2 Antigen-Rapid test-Set Device ID: 2109 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Microprofit Biotech Co., Ltd Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold Chromatographic Immunoassay) Device ID: 1967 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Microprofit Biotech Co., Ltd Commercial: SARS-CoV-2 Antigen Test Kit (Fluorescence Immunoassay) Device ID: 1968 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Microprofit Biotech Co., Ltd Commercial: SARS-CoV-2 Spike Protein Test Kit (Colloidal Gold Chromatographic Immunoassay) Device ID: 1178 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Microprofit Biotech Co., Ltd Commercial: SARS-CoV-2 Spike Protein Test Kit (Fluorescence Immunoassay) Device ID: 1228 Method: Immunoassay Target: Antigen Format: Go to details
CE Marking: Yes Manufacturer: Shenzhen Microprofit Biotech Co., Ltd. Commercial: SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay) Device ID: 2233 Method: Immunoassay Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd. Commercial: RapiSafe SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) Device ID: 2978 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Reagent Technology Co.,Ltd. Commercial: SARS-CoV-2 antigen IVD kit SWAB Device ID: 2026 Method: Immunochromatography Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Superbio Technology Co., Ltd. Commercial: 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) Device ID: 3999 Method: Immunochromatography Target: Antigen Format: Near POC / POC, Other Go to details
CE Marking: Yes Manufacturer: Shenzhen Superbio Technology Co., Ltd. Commercial: 2019-nCoV Antigen Rapid Test (Immunochromatography Assay) Device ID: 3086 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Superbio Technology Co.,Ltd. Commercial: COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay) Device ID: 3709 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Superbio Technology Co.,Ltd. Commercial: COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay) Device ID: 3270 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Superbio Technology Co.,Ltd. Commercial: COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay) Device ID: 3617 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Ultra-Diagnostics Biotec.Co.,Ltd Commercial: SARS-CoV-2 Antigen Test Kit Device ID: 2017 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Uni-medica Technology Co. Ltd Commercial: SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Device ID: 2999 Method: Immunochromatography Target: Antigen Format: Manual Go to details
CE Marking: Yes Manufacturer: Shenzhen Watmind Medical Co., Ltd Commercial: SARS-CoV-2 Ag Diagnostic Test Kit (Colloidal Gold) Device ID: 1769 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: Shenzhen Watmind Medical Co., Ltd. Commercial: SARS-CoV-2 Ag Self-test Kit (Saliva) Device ID: 3042 Method: Immunochromatography Target: Antigen Format: Near POC / POC Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: GLINE-2019-nCoV Ag Device ID: 1347 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: GLINE-2019-nCoV Ag Saliva Device ID: 1893 Method: Immunoassay Target: Antigen Format: Manual, Near POC / POC Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: iFlash-2019-nCoV Antigen Device ID: 1169 Method: Immunoassay Target: Antigen Format: Automated Go to details
CE Marking: Yes Manufacturer: SHENZHEN YHLO BIOTECH CO., Ltd Commercial: UNICELL-2019-nCoV Ag Device ID: 1170 Method: Immunoassay Target: Antigen Format: Near POC / POC Go to details

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements