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K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 




Fibrinogen Control
Cat. No.: K63C-10M
Type.: Control


KIT COMPOSITION
Level 1 Human Plasma 5 x 1 mL, lyophilized
Level 2 Human Plasma 5 x 1 mL, lyophilized
    
K63C-10M
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INTENDED USE
The K-ASSAY ®   Fibrinogen Control is intended for use in the quality control of fibrinogen assays.

FOR IN VITRO DIAGNOSTIC USE.

CONTROL PREPARATION
Reconstitute with 1.0 mL of distilled water.  Swirl gently and let stand undisturbed for 15 minutes at room temperature.  Do not invert vial or mix vigorously.

STORAGE AND HANDLING
After proper reconstitution, Level 2 Fibrinogen Control is stable for 8 hours when stored in capped vial at 2-8°C and Level 1 Fibrinogen Control is stable for 16 hours when stored in capped vial at 2-8°C.  A precipitate may form when refrigerated.  Gently warm the plasma to 37°C to minimize any precipitate.

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   Fibrinogen Control are continually being revised through ongoing quality assurance.   As a result, the expected values may change from lot to lot.  Please refer to the package insert and/or vial labels for each lot for the expected values.

 METHOD   UNIT   LEVEL 1   LEVEL 2 
 MEAN   RANGE   MEAN   RANGE 
 K-ASSAY ®  Fibrinogen 
on Hitachi 911
 mg/dL   146   117 - 175   457   365 - 548 
 K-ASSAY ®  Fibrinogen 
on Beckman Synchron CX
 mg/dL   167   134 - 201   447   358 - 537 
 Clauss Fibrinogen   mg/dL   117   N/A   524   N/A