PSA

Prostate-specific antigen (PSA) · class III · Until 10/11/2035

Registration no.: 82533950127
Process no.: 25351154340202567
Status: Until 10/11/2035
Device type: Prostate-specific antigen (PSA) (ANTÍGENO PROSTÁTICO ESPECÍFICO (PSA))
Risk class: III
Registration holder: MR SAUDE LTDA CNPJ 26.386.899/0001-16 · 201 registrations
Manufacturer: QINGDAO HIGHTOP BIOTECH CO.,LTD. · China
Published: 10/11/2025
Valid until: 10/11/2035
Last updated by ANVISA: 2026-10-12
Official record: View on ANVISA ↗

Other prostate-specific antigen (psa) registrations (71 in total, see all)

Product	Class	Holder	Published	Status
PSA FIA Assure Test 80885650110	III	ORBITAE DIAGNOSTICOS S/A	21/09/2026	Until 21/09/2036
BIOCLIN POCT FIA PSA TOTAL 10269360504	III	QUIBASA - QUIMICA BASICA LTDA	27/07/2026	Until 27/07/2036
Atellica IM total PSA II (tPSAII) 10345162561	III	SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA	04/05/2026	Until 04/05/2036
Família VITROS Immunodiagnostic Products Total PSA II Reagent Pack and Calibrator 81246986919	III	ORTHO CLINICAL DIAGNÓSTICS DO BRASIL PRODUTOS PARA SAÚDE LTDA	22/04/2026	Until 22/04/2036
PSA Total Test System - ELISA 80048490106	III	USA DIAGNOSTICA LTDA	05/01/2026	Until 05/01/2036
Família PSA Quantitative Test Kit (Time-Resolved FIA) 82444370307	III	Enzytec Biotecnologia Ltda.	29/12/2025	Until 29/12/2035
FASTLINE PSA QUALITATIVO 80105220290	III	KHAYROS DIAGNOSTICA FABRICACAO, COMERCIALIZACAO E DISTRIBUICAO DE PRODUTOS LTDA	01/12/2025	Until 01/12/2035
Total PSA Chemiluminescent Immunoassay Kit 82444370287	III	Enzytec Biotecnologia Ltda.	13/10/2025	Until 13/10/2035