FDA.reportPublic FDA data

Procalcitonin (PCT) IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.
GUDID devices
24
Last updated
2026-06-11 06:05:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B085K834M50Audit MicroControls Linearity FD ProcalcitoninAALTO SCIENTIFICK834M-52018-06-22
B085K841M50Audit MicroControls Linearity FD Procalcitonin for bioMerieux VIDASAALTO SCIENTIFICK841M-52018-03-27
08056771103022LIAISON Controls BRAHMS PCT II GENDIASORIN SPA3180912018-04-04
08056771103039LIAISON BRAHMS PCT II GEN VerifiersDIASORIN SPA3180922018-04-04
B085K814M50Linearity FD Procalcitonin for Siemens AtellicaAALTO SCIENTIFICK814M-52023-01-31
04051839013675TruLab Procalcitonin Bi-Level ControlsDiaSys Diagnostic Systems GmbH5998099430862025-08-01
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.2349452018-04-02
00630414014197Atellica IM PCT MCMSiemens Healthcare Diagnostics Inc.109982652020-09-24
00630414246567Atellica IM BRAHMS PCT QC KitSiemens Healthcare Diagnostics Inc.112027002020-09-24
00630414971186IMMULITE® Systems CAL Calibration Verification Material CalcitoninSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103736852020-09-24
10758750032938VITROSORTHO CLINICAL DIAGNOSTICS69055602020-05-16
10758750032945VITROSORTHO CLINICAL DIAGNOSTICS69055612020-05-16
04015630946594Elecsys PCT CalCheck 5Roche Diagnostics GmbH059156861902020-05-04
00859110005661ValidateLgc Clinical Diagnostics, Inc.403ab2020-03-02
00859110005678ValidateLgc Clinical Diagnostics, Inc.403ro2020-03-02
B085K894M50Audit MicroControls Linearity FD Procalcitonin for Roche SystemsAALTO SCIENTIFICK894M-52019-05-02
B085K071M60Audit MicroControls Control FD ProcalcitoninAALTO SCIENTIFICK071M-62018-03-27
B085K842M250Audit MicroControls MethodVal FD Procalcitonin bioMerieux VIDAS and miniVIDASAALTO SCIENTIFICK842M-252018-03-27
04260157632882B.R.A.H.M.S PCT sensitive KRYPTOR QC B.R.A.H.M.S GmbH825922016-08-17
04987270234167Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.2341672018-04-02
00817089020924Diazyme Procalcitonin Control SetDIAZYME LABORATORIES, INC.DZ558A-CON2017-09-05
00657498001974Procalcitonin (PCT) Bi-Level ControlsSTANBIO LABORATORY, L.P.2320-2032017-06-26
00630414599700Atellica IM PCT QCSiemens Healthcare Diagnostics Inc.109956522018-02-06
00380740153946AlinityAbbott Ireland Diagnostics01R18102019-01-04