FDA.reportPublic FDA data

Total prostate specific antigen (tPSA) IVD, calibrator

Definition
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen.
GUDID devices
11
Last updated
2023-12-11 20:29:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00380740130411AlinityAbbott Ireland Diagnostics07P92012020-11-18
07613336167496total PSA CalSet IIRoche Diagnostics GmbH088385341602020-08-24
00380740008963ARCHITECTAbbott Ireland Diagnostics6C06-012014-11-18
00630414202921ADVIA Centaur® Systems, ACS:180® Systems Calibrator QSiemens Healthcare Diagnostics Inc.103102962014-09-24
00630414202938ADVIA Centaur® Systems. ACS:180® Systems Calibrator QSiemens Healthcare Diagnostics Inc.103102952014-09-24
00630414598444Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.109955172017-12-27
00630414598451Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.109955182017-12-22
00816467020020Calibrator Kit - PSAQUALIGEN INC.TPSA Cal2016-09-16
04015630920754Elecsys Total PSA CalSet IIRoche Diagnostics GmbH044852201602014-12-18
04560189211988AIA-PACK PA CALBRATOR SETTOSOH CORPORATIONn/a2014-09-24
07613336154380total PSA Calset IIRoche Diagnostics GmbH044852201602017-09-29