ANVISA registration

SOFIA® SARS ANTIGEN FIA

Registration 81246986875. CORONAVÍRUS

Registration details

Registration number81246986875
Application number25351309316202318
Technical nameCORONAVÍRUS
Risk classIII
Published on19/06/2023
ValidityValid until 30/11/2030

Registration holder

Legal nameORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA
CNPJ21.921.393/0001-46

Manufacturer

  • QUIDEL CORPORATION ESTADOS UNIDOS DA AMÉRICA

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.

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