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Ferritin / IgE / Insulin Control
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Cat. No.:
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K59C-3M
or
K59C-L1, K59C-L2, K59C-L3
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Type.:
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Control
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KIT COMPOSITION
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Cat. No. K59C-3M
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Level 1
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Human Serum
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1 x 5 mL, liquid (frozen)
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Level 2
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Human Serum
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1 x 5 mL, liquid (frozen)
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Level 3
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Human Serum
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1 x 5 mL, liquid (frozen)
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Click Image To Enlarge
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Cat. No. K59C-L1
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Level 1
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Human Serum
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2 x 5 mL, liquid (frozen)
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Image Not Available
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Cat. No. K59C-L2
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Level 2
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Human Serum
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2 x 5 mL, liquid (frozen)
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Click Image To Enlarge
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Cat. No. K59C-L3
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Level 3
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Human Serum
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2 x 5 mL, liquid (frozen)
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Click Image To Enlarge
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INTENDED USE
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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.
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CONTROL PREPARATION
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1.
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Thaw at room temperature on a rocker or with periodic gentle inversion.
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2.
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Once thawed, immediately store at 2-8°C. ONCE THAWED, DO NOT
REFREEZE THE CONTROL.
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STORAGE AND HANDLING
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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.
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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 ®
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 |
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LEVEL 1 |
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LEVEL 2 |
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LEVEL 3 |
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MEAN |
RANGE |
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MEAN |
RANGE |
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MEAN |
RANGE |
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K-ASSAY ®
Ferritin
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Hitachi 911 |
ng/mL |
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17 |
14 - 21 |
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153 |
123 - 184 |
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361 |
289 - 434 |
| Beckman CX-7 |
ng/mL |
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19 |
16 - 23 |
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132 |
105 - 158 |
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293 |
234 - 351 |
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K-ASSAY ®
Total IgE
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Hitachi 911 |
IU/mL |
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31 |
25 - 38 |
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145 |
116 - 174 |
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296 |
237 - 355 |
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K-ASSAY ®
Insulin
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Hitachi 911 |
µIU/mL |
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6.2 |
4.9 - 7.4 |
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74.8 |
59.9 - 89.8 |
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104.2 |
83.4 - 125.0 |
| Beckman CX-7 |
µIU/mL |
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4.9 |
3.9 - 5.9 |
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77.7 |
62.2 - 93.3 |
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>99 |
N/A |
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