Cholesterol LDL HDL Calibrator, Elitech

Description

INTENDED USE
This in vitro diagnostic device is intended for the calibration of ELITech Clinical Systems reagents, used
for HDL or LDL cholesterol quantitative determination.
This in vitro diagnostic device is for professional use only.

COMPOSITION
– Lyophilized product prepared from human serum.
– The HDL and LDL concentrations of this calibrator are lot-specific.

MATERIALS REQUIRED BUT NOT PROVIDED
– ELITech Clinical Systems reagent, used for HDL or LDL cholesterol quantitative determination (Ref. HDL-XXXX or CLDL-XXXX).
– General Laboratory equipment.

TRACEABILITY
HDL LDL CALIBRATOR is traceable to the reference method approved by the CDC (Centers for Disease
Control and Prevention).

PRECAUTIONS FOR USE AND WARNINGS
– Consult Safety Data Sheet (SDS) for a proper handling.
– Each unit of human blood used in the manufacture of these products was tested and found to be negative/
non-reactive for the presence of HbsAg, HCV and HIV1/2. The methods used were FDA approved or CE
compliant. Nevertheless, since the risk of infection cannot be fully excluded these products must be handled as potentially infectious. In case of exposure, follow the guidelines of the competent health authorities.
– Take precautions when handling broken glass vials as sharp edges can injure the user.
– Take normal precautions and adhere to good laboratory practice.
– Use clean or single use laboratory equipment only to avoid contaminations.