5-PLASMA Bivalirudin Control - Human plasma-based control material intended for quality control of bivalirudin measurements using anti-IIa clotting and chromogenic assay methods.
2026-04-02
5-Diagnostics Ltd
GUDID#
5-PLASMA Bivalirudin Calibrator - Human plasma-based calibrator material intended for calibration of bivalirudin measurements using anti-IIa clotting and chromogenic assay methods. The product consists of multiple calibration levels and is intended for in vitro diagnostic use by trained laboratory professionals.
2026-04-02
5-PLASMA Bivalirudin AMR Verification Kit - The 5-PLASMA Bivalirudin AMR Verification Kit is an in vitro diagnostic reagent kit intended for the verification of the Analytical Measurement Range (AMR) of assays used to quantify bivalirudin activity or concentration in human plasma. The kit consists of five levels of plasma-based materials containing defined concentrations of bivalirudin, covering the clinically relevant measurement range of the associated assay.The kit is designed for laboratory use to verify that a coagulation analyzer or assay method performs accurately and linearly across its claimed analytical measuring range for bivalirudin. It is not intended for direct diagnostic use or patient result reporting.
2026-04-20