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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 
High-Sensitive D-Dimer Control
Cat. No.: K115C-10M
Type.: Control


KIT COMPOSITION
Cat. No. K115C-10M
Level 1 Human Plasma 5 x 0.5 mL, lyophilized
Level 2 Human Plasma 5 x 0.5 mL, lyophilized
    
K115C-10M
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
The K-ASSAY ®   High-Sensitive D-Dimer control is intended to be used as a consistent test sample of known concentration for monitoring the performance of the K-ASSAY ®   High-Sensitive D-Dimer assay.
NOT FOR USE IN THE U.S.

CONTROL PREPARATION
 1.  Reconstitue 1 vial of each control level with 0.5 mL of purified water and allow to sit for 30 minutes.

 2.  Gently swirl vial until dissolution is complete and the solution is homogenous (do not shake).

 3.  Replace the cap immediately after use to prevent evaporation or contamination.

 4.  Return the vial to 2-8°C prompty after use.

STORAGE AND HANDLING
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.

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   High-Sensitive D-Dimer 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.

 ANALYTE   LEVEL 1   LEVEL 2   Units 
 MEAN   RANGE   MEAN   RANGE 
K-ASSAY ®
High-Sensitive D-Dimer
  826     661 - 991     2207     1766 - 2648     ng/mL  
  (DDU)  
  0.826     0.661 - 0.991     2.207     1.766 - 2.648     µg/mL  
  (DDU)