6, Rue Ibn Ennafis - Z.I. Lac 3 Tunisie
Tél. : 71 182 500 - Fax : 71 182 250
www.biomaghreb.com
IVD
IN VITRO DIAGNOSTIC USE
BILIRUBIN CALIBRATOR
Direct and Indirect Method
REAGENT PRESENTATION
The calibrator consists of conjugated bilirubin and unconjugated biliru-
bin in a bovine albumin matrix. The exact concentrations are indicated
on each vial.
USE
Calibration of total and direct bilirubin assay for methods for the deter-
mination of:
- Direct Bilirubin (
REF
: 17017)
- Total Bilirubin (
REF
: 18014)
- Total and Direct Bilirubin (
REF
: 19011,
REF
:19028)
PRECAUTIONS
Biomaghreb reagents are intended for use by qualified personnel for in
vitro use (do not pipette by mouth).
• Refer to the current SDS available on request or at www.bio-
maghreb.com;
• Verify the integrity of the reagents before use; and
• Disposal of waste: comply with the legislation in force.
For safety reasons, treat any specimen or reagent of biological origin as
potentially infectious. Respect the legislation in force.
REAGENT PREPARATION
Carefully open a vial without loss of lyophilisate, and take up exactly 3
ml of distilled water.
Wait 15 minutes and then complete the dissolution by successively tur-
ning the bottle over.
Caution: Do not shake
PRESERVATION AND STABILITY
Before opening : Until the expiry date indicated on the box label stored
at 2-8°C.
After opening : Kept in the dark, the reagent is stable:
2 days at 20-25°C.
4 days at 2-8°C.
6 weeks at minutes 20°C.
ADDITIONAL EQUIPMENT
• Basic equipment of the medical analysis laboratory ;
• Spectrophotometer or Clinical Biochemistry Analyzer..
CALIBRATION
Case Standard (Reagent 4)
Recalibration is recommended in the following cases:
1. Change of reagent batch;
2. After maintenance operations on the analyzer; and
3. The control values are outside the confidence limits.
FT En 21 Date of updating : 10/ 2020 Version B
Manufacturer Use by In Vitro Diagnostic Temperature
Limitation
Catalogue number See insert Sufcient
for < n > essais
Batch number Keep away
from light
