SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) - ANVISA Registration 80885650093
Access comprehensive regulatory information for SELF-TEST FOR ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) in Brazil's medical device market through Pure Global AI's free database. This Risk Class IV medical device is registered under ANVISA number 80885650093 and manufactured by ASSURE TECH. (HANGZHOU) CO., LTD. The registration is held by ORBITAE DIAGNOSTICOS LTDA with validity until Aug 25, 2035.
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 ABBOTT RAPID DIAGNOSTICS JENA GMBH, CHEMBIO DIAGNOSTICS BRAZIL 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
80885650093
25351376489202414
11162384000165
Company Information
Dates and Status
Aug 25, 2025
25/08/2035
09/18/2025 19:00:01
FERTILITY SELF-TEST
FAMILIA AUTOTESTE DE FERTILIDADE
SANFARMA INDÚSTRIA, COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO LTDA
80015040051
Jul 08, 2024
SELF-TEST FOR HUMAN CHORIONIC GONADOTROPIN (HCG)
TESTE DE GRAVIDEZ FAMIVITA
RENYLAB QUÍMICA E FARMACÊUTICA LTDA
80002670095
Sep 25, 2017
SELF-TEST FOR HUMAN CHORIONIC GONADOTROPIN (HCG)
Autoteste HCG 10 mUI
HANGZHOU ALLTEST BIOTECH CO. LTD
80474870129
Jul 03, 2023
SELF-TEST FOR FOLLICLE STIMULATING HORMONE (FSH)
Família Teste Rápido de FSH (Urina-Jato médio) para Autoteste (FFS-103H) (Midstream)
HANGZHOU ALLTEST BIOTECH CO. LTD
81325990209
Jan 09, 2023
SELF-TEST FOR HUMAN CHORIONIC GONADOTROPIN (HCG)
Teste Rápido de Gravidez por HCG em Bastão (Urina)
ACRO BIOTECH, INC. (MONTCLAIR)
81325990085
Oct 08, 2018
ABBOTT RAPID DIAGNOSTICS JENA GMBH• Germany
CHEMBIO DIAGNOSTICS BRAZIL LTDA.• Brazil
BIOSYNEX S.A.• France
DPS INDUSTRIA, DISTRIBUICAO, COMERCIO, IMPORTACAO E EXPORTACAO LTDA• Brazil
ORASURE TECHNOLOGIES INC• United States of America
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
SAÚDE+
DPS INDUSTRIA, DISTRIBUICAO, COMERCIO, IMPORTACAO E EXPORTACAO LTDA
80861970054
Sep 15, 2025
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
Autoteste de HIV OraQuick®
ORASURE TECHNOLOGIES INC
80430080021
May 26, 2025
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
Autoteste de HIV OraQuick®
Not specified
80430080021
May 26, 2025
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
Família Teste Rápido HIV 1.2 (Sangue total) Para Autoteste
HANGZHOU ALLTEST BIOTECH CO. LTD
81325990349
May 20, 2024
AUTOTESTE PARA ANTICORPOS DO VÍRUS DE IMUNODEFICIÊNCIA HUMANA (HIV)
Família Teste Rápido HIV 1.2 (Sangue total) Para Autoteste
Not specified
81325990349
May 20, 2024