PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10310030102
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 10310030102 and manufactured by WAMA PRODUTOS PARA LABORATORIO LTDA. The registration is held by WAMA PRODUTOS PARA LABORATORIO LTDA with validity until Jan 07, 2028.
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
Need help with your Brazil registration?
Contact Pure Global Brazil TeamDevice Details
Registration Details
10310030102
25351474771200765
66000787000108
Company Information
Dates and Status
Jan 07, 2008
07/01/2028
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Imuno-Rápido Quanti PSA Total
WAMA PRODUTOS PARA LABORATORIO LTDA
10310030225
Jul 17, 2023
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
Imuno-Rápido Quanti PSA Livre
WAMA PRODUTOS PARA LABORATORIO LTDA
10310030226
Jul 31, 2023
PROSTATE-SPECIFIC ANTIGEN (PSA)
Teste Rápido Onsite PSA Semi-Quantitativo
CTK BIOTECH, INC.
80524900045
Oct 17, 2016
PROSTATE-SPECIFIC ANTIGEN (PSA)
Teste Rápido Onsite PSA Semi-Quantitativo
Not specified
80524900045
Oct 17, 2016
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device (Sangue Total/Soro/Plasma)
Not specified
10071770842
Mar 30, 2015
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