PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10377390090
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 10377390090 and manufactured by KATAL BIOTECNOLOGICA INDÚSTRIA E COMÉRCIO LTDA. The registration is held by KATAL BIOTECNOLOGICA INDUSTRIA E COMERCIO LTDA with validity until Apr 03, 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 SIEMENS HEALTHCARE DIAGNOSTICS INC., ABBOTT IRELAND DIAGNOSTIC DIVISION, 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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Registration Details
10377390090
25351063609200634
71437917000104
Company Information
Dates and Status
Apr 03, 2006
03/04/2026
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
BIOLISA PSA TOTAL
QUIBASA QUÍMICA BÁSICA LTDA
10269360364
Aug 15, 2022
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TOTAL EIA
MONOBIND INC.
80048490053
Oct 04, 2010
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TOTAL EIA
Not specified
80048490053
Oct 04, 2010
PROSTATE-SPECIFIC ANTIGEN (PSA)
Elecsys Total PSA
Not specified
10287411221
May 02, 2017
PROSTATE-SPECIFIC ANTIGEN (PSA)
Elecsys Total PSA
ROCHE DIAGNOSTICS GMBH
10287411221
May 02, 2017
SIEMENS HEALTHCARE DIAGNOSTICS INC.• United States of America
ABBOTT IRELAND DIAGNOSTIC DIVISION• Ireland
BECKMAN COULTER INC• United States of America
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