HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) - ANVISA Registration 80954880230
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 80954880230 and manufactured by Eco Diagnostica Ltda. The registration is held by Eco Diagnostica Ltda with validity until Aug 25, 2035.
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
80954880230
25351376429202400
14633154000206
Company Information
Dates and Status
Aug 25, 2025
25/08/2035
09/18/2025 19:00:01
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
TESTE RÁPIDO ONSITE HBSAG COMBO
CTK BIOTECH, INC.
80524900042
Oct 03, 2016
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
TESTE RÁPIDO ONSITE HBSAG COMBO
Not specified
80524900042
Oct 03, 2016
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
IMUNO-RAPIDO HBsAg
WAMA PRODUTOS PARA LABORATORIO LTDA
10310030063
Mar 19, 2001
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Teste Rápido em Cassete de HBsAg
Not specified
82568320003
Feb 26, 2024
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
Teste Rápido em Cassete de HBsAg
HANGZHOU ALLTEST BIOTECH CO. LTD
82568320003
Feb 26, 2024
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)
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
ANTÍGENO DE SUPERFÍCIE DE VÍRUS DA HEPATITE B (HBSAG)
ACCESS HBsAg (C39422)
BECKMAN COULTER INC
10033121082
Aug 04, 2025