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H. pylori Control
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Cat. No.:
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K242C-2M
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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 ®
H. pylori Control is intended for use as a consistent test sample of known concentration for monitoring the performance of the
K-ASSAY ® H. pylori Test Reagent
for automated chemistry analyzers.
FOR RESEARCH USE ONLY IN THE U.S.
NOT FOR DIAGNOSTIC PROCEDURES IN THE U.S.
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CONTROL PREPARATION
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Controls are liquid and ready to use.
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STORAGE AND HANDLING
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Store controls at 2-8°C. Return all controls to 2-8° promptly after use.
Unopened controls can be used for one year from the date of manufacturing as indicated by the
expiration date on the package and bottle labels. Opened controls can be used for 5 weeks if stored at 2-8°C.
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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 ®
H. pylori 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.
| REAGENT |
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LEVEL 1
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LEVEL 2
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VALUE
(U/mL) |
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VALUE
(U/mL) |
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K-ASSAY ® H. pylori Test Reagent
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5.0 |
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20.0 |
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