PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10310030137
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 10310030137 and manufactured by WAMA PRODUTOS PARA LABORATORIO LTDA. The registration is held by WAMA PRODUTOS PARA LABORATORIO LTDA with validity until Mar 05, 2027.
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
10310030137
25351021084201276
66000787000108
Company Information
Dates and Status
Mar 05, 2012
05/03/2027
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Biodetechta PSA
BIO BRASIL BIOTECNOLOGIA LTDA
80680420094
Jan 08, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
BIOLISA PSA TOTAL
QUIBASA QUÍMICA BÁSICA LTDA
10269360364
Aug 15, 2022
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010475
Oct 21, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA
IN VITRO DIAGNOSTICA LTDA
10303460530
Oct 03, 2022
PROSTATE-SPECIFIC ANTIGEN (PSA)
Biodetechta PSA FIA
BIO BRASIL BIOTECNOLOGIA LTDA
80680420074
Feb 13, 2023
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