ANVISA registration

Malária P.f/Pan Assure Test

Registration 80885650059. ANTÍGENO PARA MÚLTIPLAS ESPÉCIES DE PLASMODIUM

Registration details

Registration number80885650059
Application number25351302724202250
Technical nameANTÍGENO PARA MÚLTIPLAS ESPÉCIES DE PLASMODIUM
Risk classIV
Published on01/08/2022
ValidityValid until 01/08/2032

Registration holder

Legal nameORBITAE DIAGNOSTICOS S/A
CNPJ11.162.384/0001-65

Manufacturer

  • ASSURE TECH. (HANGZHOU) CO., LTD. CHINA, REPÚBLICA POPULAR

Source: ANVISA

Source: ANVISA open data, medical device file, updated daily. The public database provides registration validity, rather than registration status: this registration may have been cancelled before its expiry date without this being shown here. Before making purchasing, import or marketing decisions, check the ANVISA search portal.

Next step

Medical device registration with ANVISA

HSC manages the process from risk classification to liaising with the regulator, in Brazil and more than 40 other countries.

Speak to a specialist