ANVISA registration

K-teste HBsAg

Registration 80115310288. ANTÍGENO DE SUPERFÍCIE DE VÍRUS DA HEPATITE B (HBSAG)

Registration details

Registration number80115310288
Application number25351412214202290
Technical nameANTÍGENO DE SUPERFÍCIE DE VÍRUS DA HEPATITE B (HBSAG)
Risk classIV
Published on17/04/2023
ValidityValid until 17/04/2033

Registration holder

Legal nameKOVALENT DO BRASIL LTDA
CNPJ04.842.199/0001-56

Manufacturer

  • KOVALENT DO BRASIL LTDA BRASIL

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