FDA.reportPublic FDA data

Activated clotting time (ACT) IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of the activated clotting time (ACT) of a clinical specimen.
GUDID devices
11
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M525AQCHP0Actalyke QC Kit - AQC-HPHELENA LABORATORIES CORPORATIONAQC-HP2016-08-22
M525AQCLP0Actalyke QC Kit - AQC-LPHELENA LABORATORIES CORPORATIONAQC-LP2016-08-22
00817869020243Animal Plasma Control Level IIANALYTICAL CONTROL SYSTEMS INCSC-1132019-01-31
00817869020250Whole Blood Control Level IANALYTICAL CONTROL SYSTEMS INCSC-1252019-01-31
00817869020267Whole Blood Control Level IIANALYTICAL CONTROL SYSTEMS INCSC-1262019-01-31
00817869020274Whole Blood Control Level IIIANALYTICAL CONTROL SYSTEMS INCSC-1272019-01-31
00817869020311Hemotec Whole Blood Control Kit LargeANALYTICAL CONTROL SYSTEMS INCSC-125, SC-126, H2O2019-07-24
00817869020335Hemotec Whole Blood Control Kit LargeANALYTICAL CONTROL SYSTEMS INCWBC-HT-1112019-11-14
00817869020342Hemotec Whole Blood Control Kit SmallANALYTICAL CONTROL SYSTEMS INCWBC-HT-1012019-11-14
00054749001231i-STATABBOTT POINT OF CARE INC.06P17-152016-09-09
00054749001248i-STATABBOTT POINT OF CARE INC.06P17-162016-09-09