FDA.reportPublic FDA data

Free (unbound) prostate specific antigen (fPSA) 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 free (unbound) prostate specific antigen (fPSA) in a clinical specimen.
GUDID devices
9
Last updated
2020-10-02 09:28:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414971346IMMULITE® Systems fPS Calibration Verification Material Free PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103737022020-09-24
07613336166673Elecsys free PSARoche Diagnostics GmbH088286011602020-08-27
07613336166628Elecsys free PSARoche Diagnostics GmbH088286101902020-08-26
00859110005708ValidateLgc Clinical Diagnostics, Inc.406bc2020-03-02
00859110005715ValidateLgc Clinical Diagnostics, Inc.406re2020-03-02
00380740009014ARCHITECTAbbott Ireland Diagnostics6C07-102014-11-18
04015630940011Elecsys free PSARoche Diagnostics GmbH070273201902018-08-23
04015630919321Elecsys Free PSA ImmunoassayRoche Diagnostics GmbH032897881602014-09-09
04015630997053Elecsys Free PSA CalCheckRoche Diagnostics GmbH035003731902014-12-18