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Test Kit is an in vitro diagnostic (IVD) test for the rapid and quantitative measurement of the fibrin degradation product D-dimer in the plasma.


  • Flow-through immunometric assay
  • Lab-quality precision and accuracy

Specifications

Simple Procedure

  PrincipleFlow-through immunometric assay
  Sample Type
Citrated Plasma
  Sample Volume
35 𝛍L
  Test Result
D-Dimer
  Test Range

200 - 10,000 ng/mL

  Precision
CV < 10%
  Test Time
Less than 4 minutes
  Calibration

Cobas C311

Performance

Control Solution

Mean (ng/mL)

Between-Day
Between-Run
Within-Run
SDCVSDCVSDCV
496
506.4
0.76
0.15%
3.28
0.65%
22.79
4.50%
1523
1508.3
31.65
2.10%
32.64
2.16%
78.82
5.23%
5966
5965
109.08
1.83%
104.00
1.74%
323.95
5.43%


Contents

Name
Quantity
Package
Remark
TC/Test Cartridge
25 x 1
Zipper bag
Disposable
R1/Reagent
25 x 1
Zipper bag
Disposable
IC/Item Card
1
-
-
IFU/Instructions for use
1--

Test Principle