PerGrande SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic assay)

PerGrande SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatographic assay)

PerGrande BioTech Development Co., Ltd.

Germany  approval BfArM-AT-Nummer:AT 209/20

Germany  File number of the special approval of the BfArM:5640-S-031/21

ISO13485 passed

Output: 1 million pcs pur day

This test kit is with CE certificate and USA EUA confirmed by chinese government department:

CHINA CHAMBER OF COMMERCEFOR IMPORT&EXPORT OF MEDICINES &HEALTH PRODUCTS

• Name List of Medical Devices and Supplies Companies with Certification/Authorization from other Countries

• Check EN 13612 EN 13641 EN 62366 CE Regulation (EU) IVDD 98/79/EC In vitro diagnostic medical devices on this list