PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80048490015
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 80048490015 and manufactured by MONOBIND INC.. The registration is held by USA DIAGNOSTICA LTDA with validity until Oct 30, 2026.
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., 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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
80048490015
25351263442200618
02330159000108
Company Information
Dates and Status
Oct 30, 2006
30/10/2026
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
VIDAS TPSA
Not specified
10158120617
Mar 09, 2009
PROSTATE-SPECIFIC ANTIGEN (PSA)
VIDAS TPSA
BIOMERIEUX SA
10158120617
Mar 09, 2009
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA
IN VITRO DIAGNOSTICA LTDA
10303460530
Oct 03, 2022
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
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