PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 10377390222
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 10377390222 and manufactured by KATAL BIOTECNOLOGICA INDÚSTRIA E COMÉRCIO LTDA. The registration is held by KATAL BIOTECNOLOGICA INDUSTRIA E COMERCIO LTDA with validity until Apr 18, 2026.
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
10377390222
25351711404201533
71437917000104
Company Information
Dates and Status
Apr 18, 2016
18/04/2026
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA LIVRE EIA
Not specified
80048490047
May 10, 2010
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA LIVRE EIA
MONOBIND, INC
80048490047
May 10, 2010
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA Livre IMMULITE 2000
Not specified
10345160982
Nov 17, 2008
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA Livre IMMULITE 2000
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
10345160982
Nov 17, 2008
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
PSA Livre IMMULITE/IMMULITE1000
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
10345161013
Nov 24, 2008
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