PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 10287411216
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 10287411216 and manufactured by manufacturer not specified. The registration is held by ROCHE DIAGNÓSTICA BRASIL LTDA with validity until Apr 24, 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
10287411216
25351078524201709
30280358000186
Company Information
Dates and Status
Apr 24, 2017
24/04/2027
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FREE PROSTATE SPECIFIC ANTIGEN (fPSA)
MONOBIND INC.
80048490017
Nov 06, 2006
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FREE PROSTATE SPECIFIC ANTIGEN (fPSA)
Not specified
80048490017
Nov 06, 2006
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Elecsys free PSA
ROCHE DIAGNOSTICS GMBH
10287411525
Aug 17, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Família Elecsys free PSA
Not specified
10287411525
Aug 17, 2020
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA LIVRE EIA
MONOBIND, INC
80048490047
May 10, 2010
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