PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80638720091
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 80638720091 and manufactured by DIAGNÓSTICA INDÚSTRIA E COMÉRCIO LTDA - ME. The registration is held by DIAGNÓSTICA INDÚSTRIA E COMÉRCIO LTDA - ME with validity until Jul 30, 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
80638720091
25351302821201866
11462456000190
Company Information
Dates and Status
Jul 30, 2018
30/07/2028
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA RAPID TEST
DIAGNÓSTICA INDÚSTRIA E COMÉRCIO LTDA - ME
80638720171
Feb 08, 2021
PROSTATE-SPECIFIC ANTIGEN (PSA)
Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole Blood/Serum/Plasma)
Not specified
82444370175
Jan 27, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole Blood/Serum/Plasma)
ZHEJIANG ORIENT GENE BIOTECH CO., LTD.
82444370175
Jan 27, 2025
PROSTATE-SPECIFIC ANTIGEN (PSA)
IMUNO-RÁPIDO PSA
WAMA PRODUTOS PARA LABORATORIO LTDA
10310030102
Jan 07, 2008
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA Prostate Specific Antigen Semi-Quantitative Ultra Rapid Test Device (Sangue Total/Soro/Plasma)
ABON BIOPHARM (HANGZHOU) CO LTD
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