HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) - ANVISA Registration 81327670084
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 81327670084 and manufactured by HANGZHOU BIOTEST BIOTECH CO., LTD. The registration is held by DNEDX COMERCIO E SERVICOS PARA PRODUTOS DA SAUDE LTDA with validity until Jul 31, 2027.
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
81327670084
25351309464201690
22940751000120
Company Information
Dates and Status
Jul 31, 2017
31/07/2027
09/18/2025 19:00:01
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma)
ZHEJIANG ORIENT GENE BIOTECH CO., LTD.
82444370202
Feb 24, 2025
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma)
Not specified
82444370202
Feb 24, 2025
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
TOYO HBsAg CASSETTE TEST KIT
Not specified
80721060041
Aug 01, 2016
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
TOYO HBsAg CASSETTE TEST KIT
TURKLAB TIBBI MALZEMELER SANAYI VETIC. AS
80721060041
Aug 01, 2016
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
FASTLINE HBsAg
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220174
Feb 05, 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)
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