TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG) - ANVISA Registration 80105220288
Access comprehensive regulatory information for TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-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 80105220288 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 Sep 15, 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, WAMA PRODUTOS PARA LABORATORIO LTDA, 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.

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Registration Details
80105220288
25351016575202551
04299232000143
Company Information
Dates and Status
Sep 15, 2025
15/09/2035
09/18/2025 19:00:01
HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG)
FASTLINE HBsAg
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220174
Feb 05, 2024
TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG)
Antibody to Hepatitis B Surface Antigen (Anti-HBs)
Not specified
10246810308
Dec 10, 2018
TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG)
Antibody to Hepatitis B Surface Antigen (Anti-HBs)
WIENER LABORATORIOS S.A.I.C
10246810308
Dec 10, 2018
TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG)
MONOLISA ANTI-HBs PLUS
BIO-RAD
80020690167
May 21, 2007
TOTAL ANTIBODY TO HEPATITIS B VIRUS S ANTIGEN (ANTI-HBSAG)
MONOLISA ANTI-HBs PLUS
Not specified
80020690167
May 21, 2007
ROCHE DIAGNOSTICS GMBH• Germany
WAMA PRODUTOS PARA LABORATORIO LTDA• Brazil
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD.• China
ANTICORPO TOTAL PARA ANTÍGENO S DE VÍRUS DE HEPATITE B (ANTI-HBSAG)
Anti-HBs Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010471
Oct 21, 2024
ANTICORPO TOTAL PARA ANTÍGENO S DE VÍRUS DE HEPATITE B (ANTI-HBSAG)
Família VITROS Immunodiagnostic Products Anti-HBs Reagent Pack, Calibrator and Control
Not specified
81246986902
Aug 05, 2024
ANTICORPO TOTAL PARA ANTÍGENO S DE VÍRUS DE HEPATITE B (ANTI-HBSAG)
Família VITROS Immunodiagnostic Products Anti-HBs Reagent Pack, Calibrator and Control
ORTHO CLINICAL DIAGNOSTICS
81246986902
Aug 05, 2024
ANTICORPO TOTAL PARA ANTÍGENO S DE VÍRUS DE HEPATITE B (ANTI-HBSAG)
Família de Reagente, Calibradores e Controles Access HBs Ab
Not specified
10033121057
Dec 26, 2023
ANTICORPO TOTAL PARA ANTÍGENO S DE VÍRUS DE HEPATITE B (ANTI-HBSAG)
Família de Reagente, Calibradores e Controles Access HBs Ab
BECKMAN COULTER INC
10033121057
Dec 26, 2023