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K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Calibrators
 
Serum/Urine FDP Calibrator
Cat. No.: KAI-108C
Type.: Calibrator


KIT COMPOSITION
Lyophilized Human Plasma FDP 5 x 1 mL
Diluent (Tris-HCl solution) 1 x 40 mL
    
KAI-108C
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Click here for an example package insert.

Click here for the Safety Data Sheet (SDS).


INTENDED USE
The K-ASSAY ®   Serum/Urine FDP Calibrator is intended to be used for the multi-point calibration of the K-ASSAY ®   Serum/Urine FDP assay (Cat. No. KAI-107) for serum and urine samples.
FOR RESEARCH USE ONLY IN THE U.S.
NOT FOR USE IN DIAGNOSTIC PROCEDURES IN THE U.S.

CALIBRATOR PREPARATION
For Serum Samples
 1.  Add exactly 1.0 mL of diluent to a vial containing the lyophilized FDP to dissolve it and allow to sit for 30 minutes.   Swirl gently to dissolve.

 2.  Prepare 6 calibrators (A-F) using the dissolved stock and diluent.  See product package insert for details.


For Urine Samples
 1.  Add exactly 1.0 mL of diluent to a vial containing the lyophilized FDP to dissolve it and allow to sit for 30 minutes.   Swirl gently to dissolve.

 2.  Dilute the reconstituted Serum/Urine FDP Calibrator 1/25 with diluent.

 3.  Prepare 6 calibrators (A-F) using the diluted calibrator stock and diluent.  See product package insert for details.

STORAGE AND HANDLING
All stock calibrators and diluent should be stored refrigerated (2-8°C).  Return all calibrators to 2-8°C promptly after use.

Unopened calibrators can be used for 1 year from the date of manufacturing as indicated by the expiration date on the package and bottle labels.

Reconstituted calibrators can be used for 6 hours if stored at 2-8°C.

Diluted calibrators can be used for 2 hours if stored at 2-8°C.

Reconstituted stock calibrators (not diluted) can be frozen one time and stored at -20°C for up to 1 month.  Do not refreeze a second time.

Unopened diluent can be used for 2 years from the date of manufacturing as indicuated by the expiration date on the package and bottle labels.  Opened diluent can be used up to the expiration date provided that the cap is tightly closed to prevent evaporation and the solution is not contaminated.

CALIBRATOR VALUES
The following values are given as an example.  The expected values for the K-ASSAY ®   Serum/Urine FDP Calibrator 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 for each lot for the exact calibrator values.

Concentration of lyophilized Plasma FDP, reconstitued with 1.0 mL of diluent :
72 µg/mL

After reconstitution and dilution :
FOR SERUM SAMPLES
Calibrators A-F
( µg/mL )
A B C D E F
  0.0     4.5     9.0     18.0     36.0     72.0  

FOR URINE SAMPLES
Calibrators A-F
( µg/mL )
A B C D E F
  0.00     0.18     0.36     0.72     1.44     2.88