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Epithod®616 D-Dimer Kit is an in vitro diagnostic (IVD) test for the rapid and quantitative measurement of the fibrin degradation product D-Dimer in the plasma. 

Specifications

Simple Procedure

  PrincipleSandwich Immuno-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

Stago STA R Max

Performance

Control
Between day
Between run
Within run
Mean
SD
CV(%)
Mean
SD
CV(%)
Mean
SD
CV(%)
496496.9
4.01
0.81
496.9
17.82
3.59
496.9
32.43
6.53
15231480.5
12.95
0.87
1480.5
10.17
0.69
1480.5
83.30
5.63
5966.1
5996.0
42.31
0.71
5996.0
106.19
1.77
5996.0
368.56
6.15


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