ANVISA registration

FaStep Covid-19 Ag Assure Autoteste

Registration 80885650064. AUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)

Registration details

Registration number80885650064
Application number25351162299202250
Technical nameAUTOTESTE PARA ANTÍGENO DO SARS-COV-2 (CORONAVÍRUS)
Risk classIII
Published on15/08/2022
ValidityValid until 15/08/2032

Registration holder

Legal nameORBITAE DIAGNOSTICOS S/A
CNPJ11.162.384/0001-65

Manufacturer

  • ASSURE TECH. (HANGZHOU) CO., LTD. CHINA, REPÚBLICA POPULAR

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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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