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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Controls
 
Ferritin / IgE / Insulin Control
Cat. No.: K59C-3M
or
K59C-L1,   K59C-L2,   K59C-L3
Type.: Control


KIT COMPOSITION
Cat. No. K59C-3M
Level 1 Human Serum 1 x 5 mL, liquid (frozen)
Level 2 Human Serum 1 x 5 mL, liquid (frozen)
Level 3 Human Serum 1 x 5 mL, liquid (frozen)
    
K59C-3M
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).




Cat. No. K59C-L1
Level 1 Human Serum 2 x 5 mL, liquid (frozen)
    
K59C-L1
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).




Cat. No. K59C-L2
Level 2 Human Serum 2 x 5 mL, liquid (frozen)
    
K59C-L2
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).




Cat. No. K59C-L3
Level 3 Human Serum 2 x 5 mL, liquid (frozen)
    
K59C-L3
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
The K-ASSAY ®   Ferritin / IgE / Insulin Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many immunological determinations.   Include K-ASSAY ®   Ferritin / IgE / Insulin Control with patient serum specimens when assaying for any of the listed constituents.   Assay values are provided for the specific systems listed.  The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
FOR IN VITRO DIAGNOSTIC USE.

CONTROL PREPARATION
 1.  Thaw at room temperature on a rocker or with periodic gentle inversion.

 2.  Once thawed, immediately store at 2-8°C.  ONCE THAWED, DO NOT REFREEZE THE CONTROL.

STORAGE AND HANDLING
Unopened vials of K-ASSAY ®   Ferritin / IgE / Insulin Control are stable for 90 days from receipt when stored at 2-8°C.  Once opened, vials of K-ASSAY ®   Ferritin / IgE / Insulin Controls are stable for 30 days when stored tightly capped at 2-8°C.   K-ASSAY ®   Ferritin / IgE / Insulin Control maintained at -20°C is stable until the expiration date on the box.

EXPECTED VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   Ferritin / IgE / Insulin 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   ANALYZER   UNITS   LEVEL 1   LEVEL 2   LEVEL 3 
 MEAN   RANGE   MEAN   RANGE   MEAN   RANGE 
 K-ASSAY ®   Ferritin   Hitachi 911   ng/mL   17   14 - 21   153   123 - 184   361   289 - 434 
 Beckman CX-7   ng/mL   19   16 - 23   132   105 - 158   293   234 - 351 
 K-ASSAY ®   Total IgE   Hitachi 911   IU/mL   31   25 - 38   145   116 - 174   296   237 - 355 
 K-ASSAY ®   Insulin   Hitachi 911   µIU/mL   6.2   4.9 - 7.4   74.8   59.9 - 89.8   104.2   83.4 - 125.0 
 Beckman CX-7   µIU/mL   4.9   3.9 - 5.9   77.7   62.2 - 93.3   >99   N/A