Warm congratulations to Hipro that the 2019-nCoV IgM /IgG Antibody Test Kit (Colloidal Gold )
for obtaining the registration certificate from the Brazilian Health Regulatory Agency (ANVISA)!
About ANVISA
ANVISA, whose full name is Agência Nacional de Vigilância Sanitária ,is affiliated to the Brazilian
Ministry of Health and is mainly responsible for the pre and post marketing supervision of medical supplies including in vitro diagnostic products. It is equivalent to the Food and Drug Administration
(FDA) of the United States and the National Medical Products Administration (NMPA) of China.
All import and distribution of medical items in Brazil must be certified by ANVISA.
2019-nCoV IgM /IgG Antibody Test Kit from Hipro
Operation diagram:
Specimen: Whole blood/serum/plasma
Methodology: Colloidal Gold
Test time: 10mins
Operation diagram:
Specimen: Serum/plasma
Methodology: Nephelometry Immunoassay Method
Test time: 6mins
EU CE certificate
CIBG Certificate From Dutch
Palestinian certificate of Registration
The access qualification from more countries:
Currently, the 2019-nCoV IgM/IgG Antibody Test Kit from Hipro have been certified (authorized)
by medical regulatory agencies in many countries and regions such as the European Union, the
Netherlands and other countries and regions, and have been sold in the above regions.
This time, obtaining the registration certificate from the Brazilian Health Regulatory Agency (ANVISA),
which further expanded the sales scope and made greater contributions to the global epidemic
prevention and control.
