ANVISA registration

Detect SARS-CoV-2 (RT-PCR) Fast

Registration 10009010377. CORONAVÍRUS

Registration details

Registration number10009010377
Application number25351835414202136
Technical nameCORONAVÍRUS
Risk classIII
Published on16/08/2021
ValidityValid until 16/08/2031

Registration holder

Legal nameLABTEST DIAGNOSTICA S/A
CNPJ16.516.296/0001-38

Manufacturer

  • LABTEST DIAGNOSTICA S/A BRASIL

Other registrations held by LABTEST DIAGNOSTICA S/Aview all

GLICOSE PAP LIQUIFORM

10009010003

GAMA GT LIQUIFORM

10009010004

PADRAO DE BILIRRUBINA

10009010010

UREIA CE

10009010011

MAGNESIO

10009010012

CAPACIDADE DE LIGACAO DE FERRO

10009010013

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