HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) - ANVISA Registration 10158120419
Access comprehensive regulatory information for HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) in Brazil's medical device market through Pure Global AI's free database. This Risk Class IV medical device is registered under ANVISA number 10158120419 and manufactured by BIOMÉRIEUX S.A.. The registration is held by BIOMERIEUX BRASIL INDUSTRIA E COMERCIO DE PRODUTOS LABORATORIAIS LTDA with validity until Dec 18, 2026.
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 ROCHE DIAGNOSTICS GMBH, ABBOTT IRELAND DIAGNOSTICS DIVISION, 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
10158120419
250000231219937
33040635000171
Company Information
Dates and Status
Dec 18, 2001
18/12/2026
09/18/2025 19:00:01
TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG)
VIDAS ANTI-HBs TOTAL II
BIOMERIEUX SA
10158120684
Dec 22, 2014
TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG)
VIDAS ANTI-HBs TOTAL II
Not specified
10158120684
Dec 22, 2014
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
VIDAS HBsAg ULTRA (HBS)
Not specified
10158120524
Sep 22, 2004
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
VIDAS HBsAg ULTRA (HBS)
BIOMERIEUX SA
10158120524
Sep 22, 2004
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
VIDAS HBSAG ULTRA CONFIRMATION
BIOMERIEUX SA
10158120541
Apr 27, 2005
ANTÍGENO DE SUPERFÍCIE DE VÍRUS DA HEPATITE B (HBSAG)
Família HbsAg II quant II cobas e
ROCHE DIAGNOSTICS GMBH
10287411762
Sep 08, 2025
ANTÍGENO DE SUPERFÍCIE DE VÍRUS DA HEPATITE B (HBSAG)
Família HbsAg II quant II cobas e
Not specified
10287411762
Sep 08, 2025
ANTÍGENO DE SUPERFÍCIE DE VÍRUS DA HEPATITE B (HBSAG)
HbsAg Combo ECO Teste
Eco Diagnostica Ltda
80954880230
Aug 25, 2025
ANTÍGENO DE SUPERFÍCIE DE VÍRUS DA HEPATITE B (HBSAG)
FAMÍLIA DE CALIBRADOR E CONTROLE ACCESS HBsAg - DxI 9000
BECKMAN COULTER INC
10033121084
Aug 04, 2025
ANTÍGENO DE SUPERFÍCIE DE VÍRUS DA HEPATITE B (HBSAG)
FAMÍLIA DE CALIBRADOR E CONTROLE ACCESS HBsAg - DxI 9000
Not specified
10033121084
Aug 04, 2025