DiaPharma Group, Inc.

For in vitro Diagnostic Use

Intended use

For the quality control of fibrinogen assays in the abnormal range.

Summary and principle

Fibrinogen, a plasma protein, is converted to fibrin by the action of thrombin. Use of a quantitative fibrinogen control is essential in monitoring fibrinogen assays. The Low Fibrinogen Control is prepared from human citrated plasma from healthy donors, by means of a dedicated process, to provide a control with a low fibrinogen level.

It is intended for the assessment of precision and accuracy of the fibrinogen assay performed on IL Coagulation Systems in the abnormal range. Use of both normal and abnormal controls is recommended for a complete quality control program.

Reagent -- Composition, Packaging, Storage and Stability

Low Fibrinogen Control (Cat. No. 0020004210): 10 x 1 mL vials of lyophilized fresh human citrated plasma containing a reduced level of fibrinogen with buffer and stabilizers.

Unopened control is stable until the expiration date shown on the vial when stored at 2-8°C. Stability after reconstitution: 4 hours at 15-25°C or 7 days at -20°C in the original vial. For optimal stability remove control from the system and store it at 2-8°C in the original vials