ANVISA registration

SARS-CoV-2 RBD Antibody Test

Registration 80258020122. CORONAVÍRUS

Registration details

Registration number80258020122
Application number25351265230202104
Technical nameCORONAVÍRUS
Risk classIII
Published on21/06/2021
ValidityValid until 21/06/2031

Registration holder

Legal nameCEPALAB LABORATÓRIOS LTDA
CNPJ02.248.312/0001-44

Manufacturer

  • GUANGZHOU WONDFO BIOTECH CO., LTD. CHINA, REPÚBLICA POPULAR

Other registrations held by CEPALAB LABORATÓRIOS LTDAview all

TESTE DE GRAVIDEZ

80258020006

TESTE DE GRAVIDEZ PLUS

80258020007

TESTE DE GRAVIDEZ HCG STRIP CEPALAB

80258020008

TESTE DE GRAVIDEZ HCG MIDSTREAM CEPALAB

80258020009

CEPALAB Lanceta

80258020010

CEPALAB AUTO LANCETA

80258020011

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