|
D-Dimer Control
|
|
Cat. No.:
|
K92C-4M
|
|
Type:
|
Control
|
|
|
KIT COMPOSITION
|
|
|
|
|
INTENDED USE
|
The K-ASSAY ®
D-Dimer Control is intended for use as consistent test sample of known concentration for monitoring the performance of the
K-ASSAY ®
D-Dimer immunoturbidimetric assay.
FOR IN VITRO DIAGNOSTIC USE.
|
|
|
CONTROL PREPARATION
|
|
1.
|
Allow controls to come to room temperature. Remove cap carefully.
|
|
|
2.
|
Add 1.0 mL of deionized water. Let rest for 15 minutes.
|
|
|
3.
|
Invert gently until dissolved.
|
|
|
|
STORAGE AND HANDLING
|
|
Store controls at 2-8°C. After reconstitution, the controls are stable
for 1 month at 2-8°C.
Unopened controls can be used for up to 1 year from the date of manufacture,
as indicated by the expiration date on the package and bottle labels.
|
|
|
|
EXPECTED VALUES
|
The following values are given as an example. The expected values for the
K-ASSAY ®
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.
| REAGENT |
|
LEVEL 1
|
|
LEVEL 2
|
|
MEAN
(µg/mL) |
RANGE
(µg/mL) |
|
MEAN
(µg/mL) |
RANGE
(µg/mL) |
|
|
K-ASSAY ® D-Dimer
|
|
3.30 |
2.97 - 3.63 |
|
10.89 |
9.80 - 11.98 |
|
