ANVISA registration

Kit careGENE N-CoV RT-PCR

Registration 80146940028. CORONAVÍRUS

Registration details

Registration number80146940028
Application number25351292728202051
Technical nameCORONAVÍRUS
Risk classIII
Published on22/06/2020
ValidityValid until 22/06/2030

Registration holder

Legal nameBLAU FARMACEUTICA S.A.
CNPJ58.430.828/0001-60

Manufacturer

  • WELLS BIO, INC. CORÉIA DO SUL

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