ANVISA registration

DETECTA COVID

Registration 80105220117. AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)

Registration details

Registration number80105220117
Application number25351120082202272
Technical nameAUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
Risk classIII
Published on04/07/2022
ValidityValid until 04/07/2032

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.

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