PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 80105220286
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 80105220286 and manufactured by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA. The registration is held by KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA with validity until Aug 18, 2035.
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.

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🇧🇷 Brazil Regulatory Expert
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Registration Details
80105220286
25351097795202578
04299232000143
Company Information
Dates and Status
Aug 18, 2025
18/08/2035
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FASTLINE PSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220153
Dec 11, 2023
PROSTATE-SPECIFIC ANTIGEN (PSA)
FASTLINE FIA PSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220283
Jul 28, 2025
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FREE PROSTATE SPECIFIC ANTIGEN (fPSA)
Not specified
80048490017
Nov 06, 2006
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
FREE PROSTATE SPECIFIC ANTIGEN (fPSA)
MONOBIND INC.
80048490017
Nov 06, 2006
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
LIAISON fPSA
DIASORIN ITALIA S.P.A.
10339840138
Dec 27, 2001
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
ORTHO-CLINICAL DIAGNOSTICS• United Kingdom
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
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA) LIVRE
Família de Reagente, Calibradores e Controles Access Hybritech free PSA
BECKMAN COULTER INC
10033121064
May 28, 2024