ANVISA registration

Família Diazyme Direct HbA1c (Enzymatic, On-Board Lysis)

Registration 82444370046. HEMOGLOBINA GLICADA (HbA1C)

Registration details

Registration number82444370046
Application number25351216440202322
Technical nameHEMOGLOBINA GLICADA (HbA1C)
Risk classII
Published on15/05/2023
ValidityIndefinite validity

Registration holder

Legal nameEnzytec Biotecnologia Ltda.
CNPJ07.214.566/0001-65

Manufacturer

  • DIAZYME LABORATORIES, INC. 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.

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Medical device registration with ANVISA

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