PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10033121078
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 10033121078 and manufactured by manufacturer not specified. The registration is held by BECKMAN COULTER DO BRASIL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS DE LABORATÓRIO LTDA with validity until Apr 22, 2035.
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
10033121078
25351420503202424
42160812000144
Company Information
Dates and Status
Apr 22, 2025
22/04/2035
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
ACCESS HYBRITECH PSA CALIBRADORES
Not specified
10003310360
Jul 02, 2003
PROSTATE-SPECIFIC ANTIGEN (PSA)
ACCESS HYBRITECH PSA CALIBRADORES
BECKMAN COULTER INC
10003310360
Jul 02, 2003
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família de Reagente, Calibradores e Controle Access Hybritech p2PSA
BECKMAN COULTER INC
10033121077
Apr 22, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família de Reagente, Calibradores e Controle Access Hybritech p2PSA
Not specified
10033121077
Apr 22, 2025
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família de Reagente, Calibradores e Controles Access Hybritech free PSA
BECKMAN COULTER INC
10033121064
May 28, 2024
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