PROSTATE SPECIFIC ANTIGEN (PSA) FREE - ANVISA Registration 10055310918
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 10055310918 and manufactured by ABBOTT IRELAND DIAGNOSTIC DIVISION. The registration is held by ABBOTT LABORATORIOS DO BRASIL LTDA with validity until Oct 28, 2034.
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
10055310918
250000240589938
56998701000116
Company Information
Dates and Status
Oct 28, 1999
28/10/2034
09/18/2025 19:00:01
CARCINOEMBRYONIC ANTIGEN
ARCHITECT CEA Controls
ABBOTT IRELAND DIAGNOSTIC DIVISION
10055311074
Apr 02, 2001
CARCINOEMBRYONIC ANTIGEN
ARCHITECT CEA Controls
Not specified
10055311074
Apr 02, 2001
PROLACTIN
ARCHITECT PROLACTIN CONTROLS
ABBOTT LABORATORIES
10055311010
Oct 09, 2000
PROLACTIN
ARCHITECT PROLACTIN CONTROLS
ABBOTT IRELAND DIAGNOSTICS DIVISION
10055311010
Oct 09, 2000
CYTOKERATIN - CLASS II
ARCHITECT CYFRA 21-1 Controls
ABBOTT GMBH
80146501750
Apr 18, 2011
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