ANTIBODIES FOR HIV AND SYPHILIS - ANVISA Registration 80535240065
Access comprehensive regulatory information for ANTIBODIES FOR HIV AND SYPHILIS in Brazil's medical device market through Pure Global AI's free database. This Risk Class IV medical device is registered under ANVISA number 80535240065 and manufactured by CHEMBIO DIAGNOSTICS BRAZIL LTDA.. The registration is held by CHEMBIO DIAGNOSTICS BRAZIL LTDA. with validity until Aug 28, 2033.
This page provides complete technical specifications for this device, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including Eco Diagnostica Ltda, FUNDAÇÃO OSWALDO CRUZ, and 5 recent registrations in the same technical category. Pure Global AI offers free access to over 100,000+ Brazilian medical device registrations, helping global MedTech companies navigate ANVISA regulations, identify competitors, and discover partnership opportunities efficiently.

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Registration Details
80535240065
25351557050202229
09449181000102
Company Information
Dates and Status
Aug 28, 2023
28/08/2033
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS IV
COMBO HIV-HCV-HBsAg-Sífilis TESTE RÁPIDO CELER
GUANGZHOU WONDFO BIOTECH CO. LTD
80537410136
Jun 09, 2025
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS IV
COMBO HIV-HCV-HBsAg-Sífilis TESTE RÁPIDO CELER
Not specified
80537410136
Jun 09, 2025
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS IV
Família Teste Rápido Combinado em Cassete para a detecção de HBsAg/VHC/VIH/Sífilis sangue, soro, plasma
Not specified
81325990303
Oct 23, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS IV
Família Teste Rápido Combinado em Cassete para a detecção de HBsAg/VHC/VIH/Sífilis sangue, soro, plasma
ACRO BIOTECH, INC. (MONTCLAIR)
81325990303
Oct 23, 2023
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS IV
FASTLINE HIV 1.2 + p24 COMBO
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220266
Apr 22, 2025
ANTICORPOS PARA HIV E SÍFILIS
FASTLINE SÍFILIS + HIV 1/2.O
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220281
Jul 07, 2025
ANTICORPOS PARA HIV E SÍFILIS
HIV/Sífilis Combo ECO Teste
Eco Diagnostica Ltda
80954880228
May 19, 2025
ANTICORPOS PARA HIV E SÍFILIS
HIV/Sífilis Combo Assure Test
Not specified
80885650089
May 05, 2025
ANTICORPOS PARA HIV E SÍFILIS
HIV/Sífilis Combo Assure Test
ASSURE TECH. (HANGZHOU) CO., LTD
80885650089
May 05, 2025
ANTICORPOS PARA HIV E SÍFILIS
Ultra HIV/Syphilis Combo
Not specified
80074330005
Nov 18, 2024