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Urine FDP Control
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Cat. No.:
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K327C-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 ®
Serum / Urine FDP Control is intended to be used as a consistent test sample of known concentration for monitoring the performance of the
K-ASSAY ®
Urine FDP assay (Cat. No. KAI-325).
FOR RESEARCH USE ONLY IN THE U.S.
NOT FOR USE IN DIAGNOSTIC PROCEDURES IN THE U.S.
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CONTROL PREPARATION
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1.
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Reconstitue 1 vial of each control level with 0.5 mL of purified water and allow to sit for 30 minutes.
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2.
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Gently swirl vial until dissolution is complete and the solution is homogenous (do not shake).
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3.
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Replace the cap immediately after use to prevent evaporation or contamination.
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4.
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Return the vial to 2-8°C prompty after use.
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STORAGE AND HANDLING
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Store lyophilized and reconstituted controls at 2-8°C. Return all controls to 2-8°C promptly after use.
Unopened controls can be used for 2 years from the date of manufacturing as indicated by the expiration date on the package
and bottle labels.
Reconstituted controls can be used for up to 7 days if stored at 2-8°C.
Reconstituted controls can be frozen one time and stored at -20°C for up to 5 weeks. Do not refreeze a second time.
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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 ®
Urine FDP 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.
| LEVEL 1 |
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LEVEL 2 |
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Units |
| MEAN |
RANGE |
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MEAN |
RANGE |
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| 0.49 |
0.27 - 0.71 |
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2.02 |
1.11 - 2.93 |
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µg/mL |
The above example values are after diluting the
controls 1/13 with Urine FDP Calibrator Diluent.
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