ANTIBODY FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV 1 AND HIV 2) - ANVISA Registration 80686360304
Access comprehensive regulatory information for ANTIBODY FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV 1 AND HIV 2) in Brazil's medical device market through Pure Global AI's free database. This Risk Class IV medical device is registered under ANVISA number 80686360304 and manufactured by BIOSYNEX S.A.. The registration is held by MANDALA BRASIL IMPORTACAO E DISTRIBUICAO DE PRODUTO MEDICO HOSPITALAR LTDA with validity until Nov 16, 2030.
This page provides complete technical specifications for 2 related devices, regulatory compliance details, 5 similar products found using AI-powered semantic search, 5 companies making the same product including WAMA PRODUTOS PARA LABORATORIO LTDA, Eco Diagnostica Ltda, 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80686360304
25351242173202004
09117476000181
Company Information
Dates and Status
Nov 16, 2020
16/11/2030
09/18/2025 19:00:01
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
EXACTO® TEST HIV
BIOSYNEX S.A.
80686360310
Dec 28, 2020
SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV)
EXACTO® TEST HIV
Not specified
80686360310
Dec 28, 2020
ANTIBODY FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV 1 AND HIV 2)
Determine HIV-1/2
Not specified
10071770723
Jun 03, 2013
ANTIBODY FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV 1 AND HIV 2)
Determine HIV-1/2
ABBOTT DIAGNOSTICS MEDICAL CO., LTD.
10071770723
Jun 03, 2013
ANTIBODY FOR HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV 1 AND HIV 2)
HIV 1/2
EBRAM PRODUTOS LABORATORIAIS LTDA
10159820237
Jan 27, 2020
ANTICORPO PARA VÍRUS DE IMUNODEFICIÊNCIA HUMANA TIPO 1 E TIPO 2 (HIV 1 E HIV 2)
Yumizen M HIV
HORIBA INSTRUMENTS BRASIL LTDA
10347320388
Sep 01, 2025
ANTICORPO PARA VÍRUS DE IMUNODEFICIÊNCIA HUMANA TIPO 1 E TIPO 2 (HIV 1 E HIV 2)
TR HIV 1/2 - BIO-MANGUINHOS
Fundação Oswaldo Cruz - Instituto de Tecnologia em Imunobiológicos -
80142170076
Jul 28, 2025
ANTICORPO PARA VÍRUS DE IMUNODEFICIÊNCIA HUMANA TIPO 1 E TIPO 2 (HIV 1 E HIV 2)
Teste Rápido Anti-HIV 1 e 2 Bahiafarma (Ouro Coloidal)
BEIJING HOTGEN BIOTECH CO., LTD
81285200024
Jun 16, 2025
ANTICORPO PARA VÍRUS DE IMUNODEFICIÊNCIA HUMANA TIPO 1 E TIPO 2 (HIV 1 E HIV 2)
Teste Rápido Anti-HIV 1 e 2 Bahiafarma (Ouro Coloidal)
Not specified
81285200024
Jun 16, 2025
ANTICORPO PARA VÍRUS DE IMUNODEFICIÊNCIA HUMANA TIPO 1 E TIPO 2 (HIV 1 E HIV 2)
HIV 1/2 Ab Combo ECO Teste
Eco Diagnostica Ltda
80954880227
May 05, 2025