PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80022230298
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 80022230298 and manufactured by GOLD ANALISA DIAGNOSTICA LTDA. The registration is held by GOLD ANALISA DIAGNOSTICA LTDA with validity until Jul 21, 2035.
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.

Janaina dos Santos de Miranda
🇧🇷 Brazil Regulatory Expert
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Registration Details
80022230298
25351053131202505
03142794000116
Company Information
Dates and Status
Jul 21, 2025
21/07/2035
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
FASTLINE FIA PSA
KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA
80105220283
Jul 28, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TEST CASSETE FIA
HANGZHOU ALLTEST BIOTECH CO., LTD
80638720188
Jul 12, 2021
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TEST CASSETE FIA
Not specified
80638720188
Jul 12, 2021
PROSTATE-SPECIFIC ANTIGEN (PSA)
Biodetechta PSA FIA
BIO BRASIL BIOTECNOLOGIA LTDA
80680420074
Feb 13, 2023
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA TOTAL EIA
Not specified
80048490053
Oct 04, 2010
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)
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
ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA)
Família LIAISON® PSA II Gen
DIASORIN ITALIA S.P.A.
10339840563
May 05, 2025