PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 81246986724
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 81246986724 and manufactured by manufacturer not specified. The registration is held by ORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA with validity until Sep 03, 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 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
81246986724
25351457067201710
21921393000146
Company Information
Dates and Status
Aug 28, 2017
03/09/2027
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
KIT DE REAGENTE IMUNODIAGNOSTICO VITROS*PARA PSA LIVRE (fPSA)
Not specified
81246986722
Aug 28, 2017
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
KIT DE REAGENTE IMUNODIAGNOSTICO VITROS*PARA PSA LIVRE (fPSA)
ORTHO-CLINICAL DIAGNOSTICS
81246986722
Aug 28, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
Calibrador Imunodiagnóstico Vitros* para PSA Total II
ORTHO-CLINICAL DIAGNOSTICS
81246986719
Aug 28, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
Calibrador Imunodiagnóstico Vitros* para PSA Total II
Not specified
81246986719
Aug 28, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
CARTUCHO DE REAGENTE FLEX DO ANTIGENO ESPECIFICO PROSTATICO (PSA) TOTAL DIMENSION
Not specified
10345161115
Jul 27, 2009
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