FDA.reportPublic FDA data

D-dimer IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen.
GUDID devices
9
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04015630900091Tina-quant D-DimerRoche Diagnostics GmbH115564873162016-09-20
04015630914593Tina-quant D-DimerRoche Diagnostics GmbH30012453222016-09-20
00893038002326Alere Triage®Alere San Diego, Inc.981002016-09-26
00899722002733Alere Triage®Alere San Diego, Inc.98100EU2016-09-26
30014613338000TriageQUIDEL CARDIOVASCULAR INC.981002018-11-01
30014613338017TriageQUIDEL CARDIOVASCULAR INC.98100EU2018-11-01
00842768003974Dade® DIMERTEST® Latex BeadsSiemens Healthcare Diagnostics Products GmbH104457232016-09-24
00845275000870Thermo Scientific Pacific Hemostasis®Fisher Diagnostics1006512016-09-16
00816426020368K-ASSAY® D-Dimer ReagentKAMIYA BIOMEDICAL COMPANY, LLCKAI-0902016-09-16