ANVISA registration

BioFire® SpotFire®

Registration 10158120749. Instrumento para análise de ácidos nucleicos

Registration details

Registration number10158120749
Application number25351839683202333
Technical nameInstrumento para análise de ácidos nucleicos
Risk classII
Published on02/01/2024
ValidityIndefinite validity

Registration holder

Legal nameBIOMERIEUX BRASIL COMERCIO DE PRODUTOS LABORATORIAIS LTDA
CNPJ33.040.635/0001-71

Manufacturer

  • BIOFIRE DIAGNOSTICS LLC 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.

Speak to a specialist