DiaPharma Group, Inc.

For in vitro diagnostic use only.

Intended use

For the calibration of coagulation assays on IL Coagulation Systems.

Summary and principle

The Calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors by means of a dedicated process to maintain the characteristics of a Normal plasma pool. It is designed for the calibration of IL Coagulation Systems in the determination of PT, Fibrinogen, Single Factors, von Willebrand Factor, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C, Protein S, Pro-IL-Complex, Hepatocomplex and as reference plasma for APTT and TT.

Reagent -- Composition, Packaging, Storage and Stability

Calibration plasma (Cat. No. 0020003700): 10 x 1 mL vials of lyophilized human plasma containing buffer, stabilizers and preservatives.

Unopened Calibration plasma is stable until the expiration date shown on the vial when stored at 2-8°C. Stability after reconstitution:

• 24 hours at 2-8°C in the original vial for PT, Fibrinogen, APTT, TT, Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C and Protein S.
• 8 hours at 2-8°C in the original vial for Factors, Pro-IL-Complex* and Hepatocomplex*.
• 24 hours at -20°C in the original vial for PT and APTT.

Do not refreeze. For optimal stability remove Calibration plasma from the system and store it at 2-8°C in the original vial.