HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) - ANVISA Registration 80146502367
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 80146502367 and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. The registration is held by ABBOTT LABORATORIOS DO BRASIL LTDA with validity until Aug 08, 2032.
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
80146502367
25351508308202263
56998701000116
Company Information
Dates and Status
Aug 08, 2022
08/08/2032
09/18/2025 19:00:01
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Família ARCHITECT HBsAg Qualitative II
ABBOTT IRELAND DIAGNOSTICS DIVISION
80146502045
Nov 27, 2017
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Família ARCHITECT HBsAg Qualitative II
Not specified
80146502045
Nov 27, 2017
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Família ARCHITECT Anti-HBs
ABBOTT IRELAND DIAGNOSTICS DIVISION
80146502085
Mar 05, 2018
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Família ARCHITECT Anti-HBs
Not specified
80146502085
Mar 05, 2018
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Família Alinity i HBsAg Next Qualitative
Not specified
80146502371
Oct 17, 2022
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