FDA.reportPublic FDA data

Total prostate specific antigen (tPSA) 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 total prostate specific antigen (tPSA) in a clinical specimen.
GUDID devices
12
Last updated
2024-01-02 09:27:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850011135631VALIDATELgc Clinical Diagnostics, Inc.406ab2023-12-25
00380740130428AlinityAbbott Ireland Diagnostics07P92102020-11-18
10758750000968VITROSORTHO CLINICAL DIAGNOSTICS68008762020-06-06
00630414601939IMMULITE® 3RD GEN. PSA CVMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD107137252020-09-24
00380740008970ARCHITECTAbbott Ireland Diagnostics6C06-102014-11-18
00630414202952ADVIA Centaur® Systems, ACS 180® Systems PSA MCMSiemens Healthcare Diagnostics Inc.103102942014-09-24
00630414599823Atellica IM PSA MCMSiemens Healthcare Diagnostics Inc.109956642018-11-14
00630414982281IMMULITE®Systems sPS CONTROL Third Generation PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD107082952014-09-24
00816467020075Method Verification Kit - PSAQUALIGEN INC.TPSA Verifier2016-09-16
00816467020167Control Kit - PSAQUALIGEN INC.PSA Controls2016-09-16
04015630995424total PSA CalCheckRoche Diagnostics GmbH117767621602018-08-22
04560189211971AIA-PACK PA CALIBRATION VERIFICATION TEST SETTOSOH CORPORATIONn/a2014-09-24