PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10158120617
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 10158120617 and manufactured by BIOMERIEUX SA. The registration is held by BIOMERIEUX BRASIL INDUSTRIA E COMERCIO DE PRODUTOS LABORATORIAIS LTDA with validity until Mar 09, 2034.
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
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
10158120617
25351873851200819
33040635000171
Company Information
Dates and Status
Mar 09, 2009
09/03/2034
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
VIDAS FPSA
BIOMERIEUX SA
10158120355
Aug 27, 1999
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
VIDAS FPSA
Not specified
10158120355
Aug 27, 1999
PROSTATE-SPECIFIC ANTIGEN (PSA)
PROSTATE SPECIFIC ANTIGEN (tPSA)
Not specified
80048490015
Oct 30, 2006
PROSTATE-SPECIFIC ANTIGEN (PSA)
PROSTATE SPECIFIC ANTIGEN (tPSA)
MONOBIND INC.
80048490015
Oct 30, 2006
PROSTATE-SPECIFIC ANTIGEN (PSA)
BIOLISA PSA TOTAL
QUIBASA QUÍMICA BÁSICA LTDA
10269360364
Aug 15, 2022
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