PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10055310921
Access comprehensive regulatory information for PROSTATE-SPECIFIC ANTIGEN (PSA) in Brazil's medical device market through Pure Global AI's free database. This Risk Class III medical device is registered under ANVISA number 10055310921 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 SIEMENS HEALTHCARE DIAGNOSTICS INC., BECKMAN COULTER INC, 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
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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
10055310921
250000240629913
56998701000116
Company Information
Dates and Status
Oct 28, 1999
28/10/2034
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
ARCHITECT FREE PSA REAGENTS
ABBOTT IRELAND DIAGNOSTIC DIVISION
10055310934
Oct 28, 1999
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
ARCHITECT FREE PSA REAGENTS
Not specified
10055310934
Oct 28, 1999
PROSTATE-SPECIFIC ANTIGEN (PSA)
ARCHITECT TOTAL PSA CALIBRATORS
ABBOTT IRELAND DIAGNOSTIC DIVISION
10055310937
Oct 28, 1999
PROSTATE-SPECIFIC ANTIGEN (PSA)
ARCHITECT TOTAL PSA CALIBRATORS
Not specified
10055310937
Oct 28, 1999
PROSTATE-SPECIFIC ANTIGEN (PSA)
ARCHITECT TOTAL PSA CONTROLS
Not specified
10055310916
Oct 28, 1999
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
BECKMAN COULTER INC• United States of America
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.• United Kingdom
DIASORIN ITALIA S.P.A.• Italy
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
FASTLINE FIA PSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220283
Jul 28, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
FIA PSA Total
GOLD ANALISA DIAGNOSTICA LTDA
80022230298
Jul 21, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
Not specified
80102513486
Jul 14, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família AutoLumo tPSA Micropartículas (CLIA)
AUTOBIO DIAGNOSTICS CO., LTD
80102513486
Jul 14, 2025
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família LIAISON® PSA II Gen
Not specified
10339840563
May 05, 2025