Quantitative determination of D-Dimer
IVD
Store at 2 - 8ºC
PRODUCT CHARACTERISTICS
The control is a lyophilised human serum used to evaluate the
precision and accuracy of D-Dimer determinations in human
plasma or serum.
REAGENTS
DIMER-D CTRL
Human serum. Contains ProClin 300, as a
preservative.
The assigned values of D-Dimer are shown
on the below table
PRECAUTIONS
H317: Contains: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-
methyl-2H -isothiazol-3-one (3:1), reaction mass of: 5-chloro2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-
one (3:1) (Proclin 300). May produce an allergic reaction.
Follow the precautionary statements given in MSDS and label
of the product.
Components from human origin have been tested and found
negative for the presence of HBsAg, HCV and antibody to HIV
(1/2). However handle cautiously as potentially infectious.
PREPARATION
Reconstitute with 1.0 mL of distilled water. Mix thoroughly,
avoiding foam forming. Bring at room temperature for about 10
minutes before use.
STORAGE AND STABILITY
The control is stable until the expiration date on the label when
stored tightly closed at 2-8ºC and contaminations are
prevented during their use. Do not use reagents over the
expiration date.
After reconstitution, stable for 14 days at 2-8ºC or 1 month at
less than –80ºC.Freeze and thaw of the calibrator solution can
be permitted only one time for the measurement.
PROCEDURE
This control should be used in the D-Dimer reagent.
