PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 80102513409
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 80102513409 and manufactured by AUTOBIO DIAGNOSTICS CO., LTD. The registration is held by VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS 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 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
80102513409
25351438685202490
04718143000194
Company Information
Dates and Status
Apr 22, 2025
22/04/2035
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
Not specified
80102513486
Jul 14, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513486
Jul 14, 2025
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FAMÍLIA FPSA (CLIA)
Not specified
80943610088
Jun 01, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FAMÍLIA FPSA (CLIA)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
80943610088
Jun 01, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Maglumi PSA Livre (CLIA)
Not specified
80102512977
Mar 06, 2023
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
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
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família de Reagente, Calibradores e Controles Access Hybritech free PSA
BECKMAN COULTER INC
10033121064
May 28, 2024
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
ichroma™ Free PSA
BODITECH MED INC.
10350840454
Mar 25, 2024