FDA.reportPublic FDA data

Complexed prostate specific antigen (cPSA) IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of complexed prostate specific antigen (cPSA) in a clinical specimen.
GUDID devices
6
Last updated
2025-02-28 12:32:09

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B502BSB59020PSA control slidesBIO SB, INC.Control Slides, 52020-06-01
00630414601946IMMULITE® Systems PTS Calibration Verification Material PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD107137262020-09-24
00630414450872ADVIA Centaur® Systems, ACS 180® Systems cPSA MCMSiemens Healthcare Diagnostics Inc.103103802014-09-24
00630414451732ADVIA Centaur® Systems, ACS:180® Systems cPSA 1,2,3 QCSiemens Healthcare Diagnostics Inc.103103872014-09-24
00630414598697Atellica IM cPSA MCMSiemens Healthcare Diagnostics Inc.109955452018-11-14
00630414598710Atellica IM cPSA QCSiemens Healthcare Diagnostics Inc.109955472018-11-14