FDA FILING INFORMATION
Proprietary Name:
COVID-19(SARS-CoV-2)IgG Antibody Test Kit(Colloidal Gold); COVID-19(SARS-CoV-2)IgM Antibody Test Kit(Colloidal Gold); COVID-19(SARS-CoV-2)IgM/IgG Antibody Test Kit(Colloidal Gold)
Classification Name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
Product Code: QJR
DeviceClass: Not Classified
Registered Establishment Name: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD
Registered Establishment Number: 3016447251
Owner/Operator: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD
Owner/Operator Number: 10062344
Establishment Operations: Contract Manufacturer, Manufacturer
Date of FDA confirmation March 16, 2020, verified utilizing FDA U.S. Food and Drug Administration Portal
FDA Database Search string for ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD