PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 80027310322
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 80027310322 and manufactured by BIOTECNICA INDUSTRIA E COMERCIO LTDA. The registration is held by BIOTECNICA INDUSTRIA E COMERCIO LTDA with validity until Feb 22, 2033.
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
80027310322
25351201070202248
02534069000120
Company Information
Dates and Status
Feb 22, 2023
22/02/2033
09/18/2025 19:00:01
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA
IN VITRO DIAGNOSTICA LTDA
10303460530
Oct 03, 2022
PROSTATE-SPECIFIC ANTIGEN (PSA)
UMELISA PSA
CENTRO DE INMUNOENSAYO
10188410027
Apr 03, 2006
PROSTATE-SPECIFIC ANTIGEN (PSA)
UMELISA PSA
Not specified
10188410027
Apr 03, 2006
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA IMMULITE 2000
Not specified
10345160915
Sep 22, 2008
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA IMMULITE 2000
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
10345160915
Sep 22, 2008
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