HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) - ANVISA Registration 80105220174
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 80105220174 and manufactured by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA. The registration is held by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA with validity until Feb 05, 2034.
This page provides complete technical specifications for this device, 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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Registration Details
80105220174
25351322679202331
04299232000143
Company Information
Dates and Status
Feb 05, 2024
05/02/2034
09/18/2025 19:00:01
TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG)
FASTLINE HBsAb
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220288
Sep 15, 2025
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Bioline HBsAg
ABBOTT DIAGNOSTICS KOREA INC.
10071770866
Sep 28, 2015
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Bioline HBsAg
Not specified
10071770866
Sep 28, 2015
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Bioline HBsAg WB
Not specified
10071770883
Jun 26, 2017
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Bioline HBsAg WB
ABBOTT DIAGNOSTICS KOREA INC.
10071770883
Jun 26, 2017
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