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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?start_search=1&showList=1&establishmentName=ANHUI%20DEEPBLUE%20MEDICAL%20TECHNOLOGY%20CO%2E%2C%20LTD&regNum=&StateName=&CountryName=&OwnerOperatorNumber=&OwnerOperatorName=&ProductCode=&DeviceName=&ProprietaryName=&establishmentType=&PAGENUM=10&SortColumn=EstablishmentName20%25ASC&RegistrationNumber=3016447251