PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 10009010482
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 10009010482 and manufactured by LABTEST DIAGNOSTICA S/A. The registration is held by LABTEST DIAGNOSTICA S/A with validity until Oct 21, 2034.
This page provides complete technical specifications for this device, 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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Registration Details
10009010482
25351850661202324
16516296000138
Company Information
Dates and Status
Oct 21, 2024
21/10/2034
09/18/2025 19:00:01
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) FREE
KIT DE REAGENTE IMUNODIAGNOSTICO VITROS*PARA PSA LIVRE (fPSA)
Not specified
81246986722
Aug 28, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010475
Oct 21, 2024
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
ARCHITECT FREE PSA REAGENTS
ABBOTT IRELAND DIAGNOSTIC DIVISION
10055310934
Oct 28, 1999
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
ARCHITECT FREE PSA REAGENTS
Not specified
10055310934
Oct 28, 1999
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
Família de Reagente, Calibradores e Controles Access Hybritech free PSA
Not specified
10033121064
May 28, 2024
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família de Reagente, Calibradores e Controles Access Hybritech free PSA
BECKMAN COULTER INC
10033121064
May 28, 2024