PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80213250128
Access comprehensive regulatory information for PROSTATE-SPECIFIC ANTIGEN (PSA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 80213250128 and manufactured by FUJIREBIO DIAGNOSTICS AB. The registration is held by PHAREBEE DIAGNOSTICOS COMERCIO IMPORTACAO E EXPORTACAO DE PRODUTOS LTDA with validity until Jan 09, 2026.
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 SIEMENS HEALTHCARE DIAGNOSTICS INC., ABBOTT IRELAND DIAGNOSTIC 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
Need help with your Brazil registration?
Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80213250128
25351397885200512
64128853000196
Company Information
Dates and Status
Jan 09, 2006
09/01/2026
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
CanAg PSA FREE EIA
FUJIREBIO DIAGNOSTICS AB
80213250130
Jan 09, 2006
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
CanAg PSA FREE EIA
Not specified
80213250130
Jan 09, 2006
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TOTAL EIA
MONOBIND INC.
80048490053
Oct 04, 2010
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TOTAL EIA
Not specified
80048490053
Oct 04, 2010
PROSTATE-SPECIFIC ANTIGEN (PSA)
UMELISA PSA
Not specified
10188410027
Apr 03, 2006
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
BECKMAN COULTER INC• United States of America
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
DIASORIN ITALIA S.P.A.• Italy
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
FASTLINE FIA PSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220283
Jul 28, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
FIA PSA Total
GOLD ANALISA DIAGNOSTICA LTDA
80022230298
Jul 21, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
Not specified
80102513486
Jul 14, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513486
Jul 14, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família LIAISON® PSA II Gen
Not specified
10339840563
May 05, 2025