PRODUCT DESCRIPTION

In US: For Research Use Only. Not for Use in Diagnostic Procedures. The BIOPHEN™ Edoxaban Calibrator Low kit is a set of human plasmas supplemented with Edoxaban at 3 different levels intended for the calibration of Edoxaban measurements, and lyophilized. They are titrated and optimized for anti-Xa chromogenic assays such as BIOPHEN™ Heparin LRT (A221011-RUO, A221013-RUO, A221015-RUO) and BIOPHEN™ DiXaI (A221030-RUO).

BIOPHEN Edoxaban Calibrator Low is used to establish a calibration curve to measure Edoxaban levels by chromogenic methods (low range). Learn more.

PRODUCT CHARACTERISTICS

The Edoxaban calibration plasmas are qualified against and Internal Standard Reference, whose qualification is linked to the referenced method by HPLC-MS/MS.

The calibrators target values are determined from multi-reagent (BIOPHENâ„¢ Heparin LRT and BIOPHENâ„¢ DiXaI) and multi-instrument (Sysmex CS-series or equivalent) tests.

The calibrator concentrations may vary slightly from one batch to the next. For the assay, see the exact values provided on the flyer provided with the kit used.

PRODUCT COMPONENTS

CAL I: 4×1 mL Lyophilized human plasma containing no Edoxaban.

CAL II: 4×1 mL Lyophilized human plasma containing a titrated quantity of Edoxaban of approximately 50 ng/mL.

CAL III: 4×1 mL Lyophilized human plasma containing a titrated quantity of Edoxaban of approximately 100 ng/mL.

PRODUCT APPLICATION