ANVISA registration

Diagnostic Kit for Dengue Virus NS1 Antigen (ELISA)

Registration 82149920110. DENGUE

Registration details

Registration number82149920110
Application number25351258224202435
Technical nameDENGUE
Risk classIII
Published on17/03/2025
ValidityValid until 17/03/2035

Registration holder

Legal nameGENESTAR INOVAÇÕES E EQUIPAMENTOS MÉDICOS LTDA
CNPJ35.489.323/0001-75

Manufacturer

  • BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD CHINA, REPÚBLICA POPULAR

Other registrations held by GENESTAR INOVAÇÕES E EQUIPAMENTOS MÉDICOS LTDAview all

Kit de Detecção de PCR em Tempo Real SARS-CoV-2 / SARS-CoV Multiplex

82149920001

Kit de Detecção de PCR em Tempo Real Multiplex SARS-CoV-2 / Influenza

82149920002

Kit de Extração de DNA PREP-NA-FET

82149920003

Kit de Detecção de PCR em Tempo Real Multiplex Painel AVRI

82149920004

Kit de Detecção de PCR em Tempo Real Quantitativo HPV-QUANT-21

82149920005

TANBead® Nucleic Acid Extraction Kit

82149920006

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