CERTIFICATES

JOYSBIO’s factory is certified by ISO 9001 and ISO 13485 quality management systems with CE 0197 notified body.Our lateral flow IVD rapid test kits are CE certified. We provide all documentations to support you on product registration and licensing with local Food and Drug Administration agency.

ISO 13485 JOYSBIO Biotechnology

ISO 13485 (1/2)

ISO 13485 JOYSBIO Biotechnology

ISO 13485 (2/2)

CE Certificates for 7 JOYSBIO IVD Products

CE Certificates for 7 JOYSBIO IVD Products

Patent Certificates

Patent Certificates

SARS-COV-2 Antigen Rapid Test FDA EUA Acknowledgment Letter

SARS-COV-2 Antigen Rapid Test FDA EUA Acknowledgment Letter

Declaration of Conformity - COVID-19 Ag Rapid Test Kit

Declaration of Conformity -SARS-COV-2 Antigen Rapid Test Kit

CE-IVD COVID-19 Ag, NAb and others_Page_1

CE-IVD COVID-19 Ag, NAb and others (1/2)

CE-IVD COVID-19 Ag, NAb and others_Page_2

CE-IVD COVID-19 Ag, NAb and others (2/2)

CE Certificate - COVID-19 (1/2)

CE Certificate - COVID-19 (2/2)

DECLARATION OF CONFORMITY JOYSBIO Lateral Flow Test

Declaration of Conformity

Brazil ANVISA GMP

Brazil ANVISA GMP

JOYSBIO COVID-19 Ab Test Mexico Registration

JOYSBIO COVID-19 Ab Test Mexico Registration

FDA EUA Acknowledgment Letter - COVID-19

COVID-19 Ab WHO EUL Submission

COVID-19 Ab WHO EUL Submission

COVID-19 Ab Brazil ANVISA

COVID-19 Ab Brazil ANVISA