ANVISA registration

FASTLINE FIA COVID-19 IgG/IgM

Registration 80105220303. CORONAVÍRUS

Registration details

Registration number80105220303
Application number25351021916202691
Technical nameCORONAVÍRUS
Risk classIII
Published on11/05/2026
ValidityValid until 11/05/2036

Manufacturer

  • KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS 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.

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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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