PROSTATE-SPECIFIC ANTIGEN (PSA) - ANVISA Registration 10350840281
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 10350840281 and manufactured by BODITECH MED INC.. The registration is held by BIOSYS LTDA with validity until Jan 18, 2036.
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
10350840281
25351556600201517
02220795000179
Company Information
Dates and Status
Jan 18, 2016
18/01/2036
09/18/2025 19:00:01
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
ichroma™ Free PSA
Not specified
10350840454
Mar 25, 2024
PROSTATE SPECIFIC ANTIGEN (PSA) FREE
ichroma™ Free PSA
BODITECH MED INC.
10350840454
Mar 25, 2024
PROSTATE-SPECIFIC ANTIGEN (PSA)
PSA IMC
BIOTECNICA INDUSTRIA E COMERCIO LTDA
80027310322
Feb 22, 2023
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família AFIAS PSA Neo
Not specified
10350840436
May 15, 2023
PROSTATE-SPECIFIC ANTIGEN (PSA)
Família AFIAS PSA Neo
BODITECH MED INC.
10350840436
May 15, 2023
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