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Fibrinogen Control
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Cat. No.:
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K63C-10M
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Type:
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Control
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KIT COMPOSITION
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INTENDED USE
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The K-ASSAY ®
Fibrinogen Control is intended for use in the quality control of fibrinogen assays.
FOR IN VITRO DIAGNOSTIC USE.
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CONTROL PREPARATION
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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.
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STORAGE AND HANDLING
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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.
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EXPECTED VALUES
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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 |
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LEVEL 1 |
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LEVEL 2 |
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MEAN |
RANGE |
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MEAN |
RANGE |
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K-ASSAY ® Fibrinogen
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mg/dL |
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146 |
117 - 175 |
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457 |
365 - 548 |
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Clauss Fibrinogen
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mg/dL |
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117 |
N/A |
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524 |
N/A |
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