FDA.reportPublic FDA data

D-dimer 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 D-dimer protein in a clinical specimen.
GUDID devices
47
Last updated
2026-08-28 10:31:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00630414634234INNOVANCE D-Dimer 2.0 Control 3Siemens Healthcare Diagnostics Products GmbH108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 2Siemens Healthcare Diagnostics Products GmbH108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 1Siemens Healthcare Diagnostics Products GmbH108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 1Siemens Healthcare Diagnostics Products GmbH108740912026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 2Siemens Healthcare Diagnostics Products GmbH108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 3Siemens Healthcare Diagnostics Products GmbH108740932026-08-19
B085K845M50Audit MicroControls Linearity FD D-Dimer for bioMerieux VIDASAALTO SCIENTIFICK845M-52019-02-14
00840094447455Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1202023-01-13
00840094447462Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1302023-01-13
00840094447479Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1402023-01-13
00840094447486Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1502023-01-13
00840094447493Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1102023-01-13
00840094447509Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-2402023-01-13
00840094453449Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1202023-01-13
00840094453456Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1302023-01-13
00840094453463Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1402023-01-13
00840094453470Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1502023-01-13
00840094453487Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-1102023-01-13
00840094453494Naida™ CI M90 Sound ProcessorAdvanced Bionics, LLCCI-5293-2402023-01-13
04015630904204D-Dimer Control I/IIRoche Diagnostics GmbH115565092162016-09-20
00630414640181INNOVANCE D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbH108738552024-03-25
B085K958M50Audit MicroControls Linearity FD D-Dimer for Stago SystemsAALTO SCIENTIFICK958M-52023-06-06
00195226000511HemosIL D-Dimer Controls INSTRUMENTATION LABORATORY COMPANY00226600302021-08-15
08426950063179HemosIL D-Dimer ControlsINSTRUMENTATION LABORATORY COMPANY000200086102016-09-23
08426950482970HemosIL D-Dimer HS 500 ControlsINSTRUMENTATION LABORATORY COMPANY000205002002016-09-23
08426950498032HemosIL AcuStar D-Dimer ControlsINSTRUMENTATION LABORATORY COMPANY00098021002016-09-23
08426950584933HemosIL D-Dimer HS 500 Controls (Liquid)INSTRUMENTATION LABORATORY COMPANY000200131002016-09-23
08426951024032HemosIL D-Dimer HS 500 Controls (Liquid)INSTRUMENTATION LABORATORY COMPANY00225500302018-03-07
15099590070588AUBeckman Coulter, Inc.ODC00292016-09-24
15391521420777TriniCHECK™ D-Dimer 1TCOAG IRELAND LIMITEDT43032016-09-12
15391521420784TriniCHECK™ D-Dimer 2TCOAG IRELAND LIMITEDT43042016-09-12
15391521420791TriniCHECK™ D-Dimer 3TCOAG IRELAND LIMITEDT43052016-09-12
B085K072M60Audit MicroControls Control FD D-DimerAALTO SCIENTIFICK072M-62018-03-27
B085K717M50Audit MicroControls Linearity FD D-DimerAALTO SCIENTIFICK717M-52018-03-27
B085K883M50Audit MicroControls Linearity FD D-Dimer PATHFAST ImmunoanalyzerAALTO SCIENTIFICK883M-52018-03-27
B085K893M50Audit MicroControls Linearity FD D-Dimer Siemens StratusAALTO SCIENTIFICK893M-52018-03-27
00842768023668INNOVANCE® D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbH104460062016-09-24
00845275000894Thermo Scientific Pacific Hemostasis®Fisher Diagnostics1006562016-09-16
00847661004479LiquichekBIO-RAD LABORATORIES, INC.271002016-09-12
00847661004486LiquichekBIO-RAD LABORATORIES, INC.271012016-09-12
00847661004493LiquichekBIO-RAD LABORATORIES, INC.271022016-09-12
00847661004509LiquichekBIO-RAD LABORATORIES, INC.271032016-09-12
00847661004516LiquichekBIO-RAD LABORATORIES, INC.27102X2016-09-12
00859110005067ValidateLgc Clinical Diagnostics, Inc.902il2016-09-23
00859110005074ValidateLgc Clinical Diagnostics, Inc.902st2017-01-16
00859110005081ValidateLgc Clinical Diagnostics, Inc.902se2017-06-26
00817089020542DiazymeDIAZYME LABORATORIES, INC.DZ179A-CON2016-11-03