Multiple coagulation marker IVD, kit, clotting

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen, using a clotting method.
GUDID devices
12
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test CartridgeLUMINEX CORPORATION20-006-0012019-12-05
00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATION30-001-0012019-12-05
04260160470327ROTEM®Tem Innovations GmbHsigma complete + hep2022-10-04
B55880004011Sonoclot® kACT KitSIENCO, INC.800-04012021-07-19
B55880004111Sonoclot® gbACT+ KitSIENCO, INC.800-04112021-05-26
B55880004121Sonoclot® gbACT+ KitSIENCO, INC.800-04122021-05-26
B55880004251Sonoclot® NonActivated KitSIENCO, INC.800-04252021-07-19
B55880004261Sonoclot® NonActivated KitSIENCO, INC.800-04262021-07-19
B55880004311Sonoclot® SonACT KitSIENCO, INC.800-04312021-07-19
B55880004321Sonoclot® SonACT KitSIENCO, INC.800-04322021-07-19
B55880004411Sonoclot® aiACT KitSIENCO, INC.800-04412021-07-19
B55880004421Sonoclot® aiACT KitSIENCO, INC.800-04422021-07-19