PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 81246986718
Access comprehensive regulatory information for PROSTATE SPECIFIC ANTIGEN (PSA) FREE in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 81246986718 and manufactured by ORTHO-CLINICAL DIAGNOSTICS. 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 ABBOTT IRELAND DIAGNOSTIC DIVISION, DIASORIN ITALIA S.P.A., 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
81246986718
25351457048201793
21921393000146
Company Information
Dates and Status
Aug 28, 2017
03/09/2027
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Calibrador Imunodiagnóstico Vitros* para PSA Total II
Not specified
81246986719
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) FREE
Calibrador fPSA
Not specified
10345161785
Dec 07, 2010
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Calibrador fPSA
SIEMENS HEALTHCARE DIAGNIOSTICS INC.
10345161785
Dec 07, 2010
PROSTATE-SPECIFIC ANTIGEN (PSA)
CALIBRADOR DE PSA TOTAL E LIVRE DIMENSION
Not specified
10345161571
Sep 08, 2009
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
DIASORIN ITALIA S.P.A.• Italy
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA• Brazil
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
FASTLINE FIA fPSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220286
Aug 18, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família AutoLumo Micropartículas de fPSA (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513409
Apr 22, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família AutoLumo Micropartículas de fPSA (CLIA)
Not specified
80102513409
Apr 22, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
fPSA Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010482
Oct 21, 2024
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família de Reagente, Calibradores e Controles Access Hybritech free PSA
Not specified
10033121064
May 28, 2024