PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80537410094
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 80537410094 and manufactured by manufacturer not specified. The registration is held by CELER BIOTECNOLOGIA S/A with validity until May 03, 2031.
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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Contact Pure Global Brazil TeamRelated Devices (2)
Registration Details
80537410094
25351194726202188
04846613000103
Company Information
Dates and Status
May 03, 2021
03/05/2031
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
Kit de Teste Rápido Antígeno Prostático Específico (PSA) (Teste Imunocromatográfico por Fluorescência)
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.
82444370101
Apr 15, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
Kit de Teste Rápido Antígeno Prostático Específico (PSA) (Teste Imunocromatográfico por Fluorescência)
Not specified
82444370101
Apr 15, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA ONE STEP TESTE
ALAMAR TECNO CIENTÍFICA LTDA
10252080075
Sep 21, 2001
PROSTATE-SPECIFIC ANTIGEN (PSA)
IMUNO-RÁPIDO PSA
WAMA PRODUTOS PARA LABORATORIO LTDA
10310030102
Jan 07, 2008
PROSTATE-SPECIFIC ANTIGEN (PSA)
Teste Rápido Onsite PSA Semi-Quantitativo
CTK BIOTECH, INC.
80524900045
Oct 17, 2016
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