FDA.reportPublic FDA data

Multiple tissue-associated protein/tumour marker IVD, control

Definition
A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen.
GUDID devices
31
Last updated
2026-06-11 06:05:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.115381872026-05-29
B085K924M100Audit MicroControls Linearity FD Tumor Markers for Roche SystemsAALTO SCIENTIFICK924M-102025-12-18
B085K939M100Audit MicroControls Linearity FD Tumor Markers for Abbott SystemsAALTO SCIENTIFICK939M-102025-11-26
00847661004080Quest DiagnosticsBIO-RAD LABORATORIES, INC.9552023-10-09
00847661001416LyphochekBIO-RAD LABORATORIES, INC.3672020-09-14
00847661001423LyphochekBIO-RAD LABORATORIES, INC.3682020-09-14
00847661001430LyphochekBIO-RAD LABORATORIES, INC.3692020-09-14
00847661001447LiquichekBIO-RAD LABORATORIES, INC.5472020-09-14
00847661001454LiquichekBIO-RAD LABORATORIES, INC.5482020-09-14
00847661001461LiquichekBIO-RAD LABORATORIES, INC.5492020-09-14
00847661003403LyphochekBIO-RAD LABORATORIES, INC.368X2020-09-14
00847661003410LiquichekBIO-RAD LABORATORIES, INC.548X2020-09-14
00847661004370LiquichekBIO-RAD LABORATORIES, INC.271142020-09-14
00847661004387LiquichekBIO-RAD LABORATORIES, INC.271152020-09-14
00847661004394LiquichekBIO-RAD LABORATORIES, INC.271162020-09-14
00847661004578LiquichekBIO-RAD LABORATORIES, INC.27115X2020-09-14
03610522046041InteliQBIO-RAD LABORATORIES, INC.120082892020-09-14
03610522046058InteliQBIO-RAD LABORATORIES, INC.120082902020-09-14
03610522046065InteliQBIO-RAD LABORATORIES, INC.120082912020-09-14
03610522046072InteliQBIO-RAD LABORATORIES, INC.120082922020-09-14
04015630938780Elecsys PreciControl Tumor MarkerRoche Diagnostics GmbH117764521602016-09-20
B085K070M60Audit MicroControls Control FD Tumor MarkersAALTO SCIENTIFICK070M-62018-03-27
B085K079M60Audit MicroControls Control FD HE4, HER2 Tumor MarkersAALTO SCIENTIFICK079M-62018-03-27
B085K719M50Audit MicroControls Linearity FD Tumor MarkersAALTO SCIENTIFICK719M-52018-06-22
B085K738M50Audit MicroControls Linearity FD HE4, HER2 Tumor MarkersAALTO SCIENTIFICK738M-52018-03-27
B085K805M50Audit MicroControls Linearity FD Tumor Markers Siemens AtellicaAALTO SCIENTIFICK805M-52019-02-14
00884883002449MAS T-Marker Liquid Assayed Tumor Marker ControlMicrogenics CorporationTUM-1012017-04-28
00884883002456MAS T-Marker Liquid Assayed Tumor Marker ControlMicrogenics CorporationTUM-2022017-04-28
00884883002463MAS T-Marker Liquid Assayed Tumor Marker ControlMicrogenics CorporationTUM-3032017-04-28
00884883003804MAS T-Marker Liquid Assayed Tumor Marker ControlMicrogenics CorporationTUM-S12017-04-28