HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV) ANTIGEN AND ANTIBODY - ANVISA Registration 80146501295
Access comprehensive regulatory information for HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 AND TYPE 2 (HIV) ANTIGEN AND ANTIBODY in Brazil's medical device market through Pure Global AI's free database. This Risk Class IV medical device is registered under ANVISA number 80146501295 and manufactured by manufacturer not specified. The registration is held by ABBOTT LABORATORIOS DO BRASIL LTDA with validity until Oct 10, 2025.
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 GMBH, 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
80146501295
25351273662200480
56998701000116
Company Information
Dates and Status
Oct 10, 2005
10/10/2025
09/18/2025 19:00:01
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
CONTROL SERUM 1
BECKMAN COULTER IRELAND INC.
10033120753
Nov 05, 2012
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
IMMUNO CONTROLS
SENTINEL CH SPA
80146501909
Jan 12, 2015
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
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
CONTROL SERUM 2
BECKMAN COULTER IRELAND INC.
10033120755
Nov 05, 2012
COMBINED PARAMETERS IN THE SAME PRODUCT - CLASS II
CONTROLE NEGATIVO SOROLÓGICO (SEROLOGY CONTROL -)
RANDOX LABORATORIES LTD
80158990327
Jul 14, 2025
ANTÍGENO E ANTICORPO DO VÍRUS DA IMUNODEFICIÊNCIA HUMANA ADQUIRIDA TIPO 1 E TIPO 2 (HIV)
HIV Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)
Not specified
82444370201
Feb 24, 2025
ANTÍGENO E ANTICORPO DO VÍRUS DA IMUNODEFICIÊNCIA HUMANA ADQUIRIDA TIPO 1 E TIPO 2 (HIV)
HIV Ag/Ab Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)
ZHEJIANG ORIENT GENE BIOTECH CO., LTD.
82444370201
Feb 24, 2025
ANTÍGENO E ANTICORPO DO VÍRUS DA IMUNODEFICIÊNCIA HUMANA ADQUIRIDA TIPO 1 E TIPO 2 (HIV)
HIV Ag/Ab Combo Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010470
Oct 21, 2024
ANTÍGENO E ANTICORPO DO VÍRUS DA IMUNODEFICIÊNCIA HUMANA ADQUIRIDA TIPO 1 E TIPO 2 (HIV)
Teste rápido em cassete de HIV 1.2
Not specified
82568320001
Feb 26, 2024
ANTÍGENO E ANTICORPO DO VÍRUS DA IMUNODEFICIÊNCIA HUMANA ADQUIRIDA TIPO 1 E TIPO 2 (HIV)
Teste rápido em cassete de HIV 1.2
HANGZHOU ALLTEST BIOTECH CO. LTD
82568320001
Feb 26, 2024