Quantitative determination of D-Dimer
IVD
Store at 2 - 8ºC
PRODUCT CHARACTERISTICS
The calibrator is a lyophilised human serum containing an D-Dimer concentration suitable to calibrate D-Dimer determinations in human serum or plasma.
REAGENTS
DIMER-D CAL
Calibrator. Human serum. Contains Proclin 300, as a preservative.
The assigned values of D-Dimer are stated on the vial label.
PRECAUTIONS
H317: Contains: 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one (3:1), reaction mass of: 5- chloro-2-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 0.5 mL of distilled water. Mix thoroughly, avoiding foam forming. Bring at room temperature for about
10 minutes before use.
STORAGE AND STABILITY
The calibrator 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 calibrator should be used in the D-Dimer reagent.
