DiaPharma Group, Inc.

DISCONTINUED -- REPLACEMENT: 20003110 (HemosIL Normal Control Assayed)

For in vitro diagnostic use.

Intended Use

For the Quality Control of coagulation assays in the normal range.

Summary and Principle

The Normal Control is prepared using human citrated plasma from healthy donors. It is intended for the assessment of precision and accuracy of tests: Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C, Protein S, and Factor VIII. Values for all analytes are within the normal range.

Reagents -- Composition, Packaging, Storage and Stability

Control Plasma Normal: 10 vials of lyophilized human plasma containing buffer, stabilizers and preservatives. Unopened Control Plasma is stable until the expiration date shown on the vial when stored at 2-8°C. Stability after reconstitution:

• Antithrombin: 24 hours at 15°C; 24 hours at 2-8°C
• Plasminogen: 24 hours at 15°C; 24 hours at 2-8°C
• Plasmin Inhibitor: 24 hours at 15°C; 24 hours at 2-8°C
• Protein C: 24 hours at 15°C; 24 hours at 2-8°C
• Factor VIII: 4 hours at 15°C; 8 hours at 2-8°C
• Protein S: 4 hours at 15°C; 24 hours at 2-8°C

For optimal stability remove control from the system and store it at 2-8°C in the original vial.