PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10009010475
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 10009010475 and manufactured by LABTEST DIAGNOSTICA S/A. The registration is held by LABTEST DIAGNOSTICA S/A with validity until Oct 21, 2034.
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
10009010475
25351725049202314
16516296000138
Company Information
Dates and Status
Oct 21, 2024
21/10/2034
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
fPSA Reagent Kit
LABTEST DIAGNOSTICA S/A
10009010482
Oct 21, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
ARCHITECT TOTAL PSA REAGENTS
Not specified
10055310921
Oct 28, 1999
PROSTATE-SPECIFIC ANTIGEN (PSA)
ARCHITECT TOTAL PSA REAGENTS
ABBOTT IRELAND DIAGNOSTIC DIVISION
10055310921
Oct 28, 1999
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
ARCHITECT FREE PSA REAGENTS
ABBOTT IRELAND DIAGNOSTIC DIVISION
10055310934
Oct 28, 1999
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
ARCHITECT FREE PSA REAGENTS
Not specified
10055310934
Oct 28, 1999
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