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