ANVISA registration

HIV 1/2 Tri-line Rapid Test Device (Whole Blood/Serum/Plasma)

Registration 82444370245. ANTICORPO DO VIRUS DA IMUNODEFICIÊNCIA HUMANA ADQUIRIDA TIPO 1, TIPO 2 E TIPO 1 SUBGRUPO O (HIV)

Registration details

Registration number82444370245
Application number25351264062202474
Technical nameANTICORPO DO VIRUS DA IMUNODEFICIÊNCIA HUMANA ADQUIRIDA TIPO 1, TIPO 2 E TIPO 1 SUBGRUPO O (HIV)
Risk classIV
Published on26/05/2025
ValidityValid until 26/05/2035

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