ANVISA registration

HCV Hepatitis C Virus Rapid Test (Whole blood/Serum/Plasma) (Cassette)

Registration 82444370191. ANTICORPO TOTAL PARA VÍRUS DE HEPATITE C (ANTI-HCV)

Registration details

Registration number82444370191
Application number25351220471202469
Technical nameANTICORPO TOTAL PARA VÍRUS DE HEPATITE C (ANTI-HCV)
Risk classIV
Published on10/02/2025
ValidityValid until 10/02/2035

Registration holder

Legal nameEnzytec Biotecnologia Ltda.
CNPJ07.214.566/0001-65

Manufacturer

  • ZHEJIANG ORIENT GENE BIOTECH 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