ANVISA registration

STANDARD Q COVID-19 IgM/IgG Combo Test

Registration 80954880138. CORONAVÍRUS

Registration details

Registration number80954880138
Application number25351421278202010
Technical nameCORONAVÍRUS
Risk classIII
Published on09/07/2020
ValidityValid until 09/07/2030

Registration holder

Legal nameEco Diagnostica Ltda
CNPJ14.633.154/0002-06

Manufacturer

  • SD BIOSENSOR, INC. CORÉIA DO SUL

Other registrations held by Eco Diagnostica Ltdaview all

Rotavírus Ag Eco Teste

80954880001

Vitamina D Eco Teste

80954880002

hCG 10mUI Eco Teste

80954880003

hCG 25mUI Eco Teste

80954880004

Troponina I Eco Teste

80954880006

Sangue Oculto Eco Teste

80954880008

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