Produkte/Klinische Chemie/Kontrollen/Kontrollseren/Haemoglobin A1C Control Set

Haemoglobin A1c Control Set 

Artikel-Nr.: KG5072
Inhalt:  2 x 2 x 0.5 ml 

INTENDED USE
This product is intended for in-vitro diagnostic use in the quality control of HbA1c on clinical chemistry systems.                                                                                                                                             

SAFETY PRECAUTIONS AND WARNINGS                      
The level 1 & level 2 controls contain human blood.

Warning:  Potentially Biohazardous Material.

Human source material from which this product has been derived has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-REACTIVE.  FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.
For in-vitro diagnostic use only, do not pipette by mouth, exercise the normal precautions required for handling laboratory reagents.

STORAGE AND STABILITY
The level 1 & level 2 controls are stable up to expiry as supplied.

The reconstituted control is stable for 1 month when stored refrigerated at 2 - 8°C.                  

NB.  Do not freeze the reconstituted controls.

PREPARATION FOR USE/RECONSTITUTION

  1. Remove the cap from the control bottle.
  2. Add 0.5 ml of double deionised water to the control.
  3. Replace control bottle cap.  Swirl the bottle several times and leave to stand at room temperature for 15 minutes.
  4. After 15 minutes, coat all surfaces of the bottle by rotating and inverting the bottle.
    Continue mixing until the solution is homogeneous and all lyophilised material is reconstituted.

NB.  Controls are treated the same as samples and in accordance with kit or reagent being used.  Use with BGT Kit will require pretreatment in order to assay for HbA1c & Total Haemoglobin.  Mix 10 ml of the reconstituted control with 400 ml of haemoglobin denaturant reagent (1:41 dilution).

MATERIALS PROVIDED
Level 1 Control:                         2 x 0.5 ml       (HbA1c CONTROL 1)
Level 2 Control:                         2 x 0.5 ml       (HbA1c CONTROL 2)

MATERIALS REQUIRED BUT NOT PROVIDED
Double Deionised Water
Volumetric pipette

ASSIGNED % HbA1c VALUES
Each batch of HbA1c control is submitted to a number of external laboratories and values are assigned from a consensus of results obtained by these laboratories.
If a method is unavailable, contact BGT BioGenTechnologies GmbH,  Tel: 02551/4090 or email info@biogentechnologies.de.


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img/page/needfull/ce-zeichen.gif Hersteller:

Guenter Keul GmbH
Günter Keul GmbH
Von-Langen-Weg 10
D-48565 Steinfurt
Tel.: 02551/2097  Fax.: 02551/80883
Web: www.keul.de



 
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