products/Blood count controls/Haemoglobin Standard

Haemoglobin Standard Set

Product no.: 3074
Ch.-B.: 113
Verw. bis: 08/2003

Low
5,9 g/dl
3.7 mmol/l
Medium
13,7 g/dl
8.5 mmol/l
Normal
18,2 g/dl
11.3 mmol/l

These standards are intended FOR IN VITRO DIAGNOSTIC USE.

Storage and stability

- Standards should be stored at 2-8°C.
- Opened ampoules are to be used within 2 weeks, avoiding evaporation and if stored as indicated.
- Standards are stable until expiry date on label, if stored as indicated (at least 1 year after Production).

Procedure

  1. Prior to Use, ampoules should be placed at room temperature for at least one hour.
  2. Immediate before Use, swirl the ampoule by inverting for at least 30 seconds. The ampoule should be held between the thump and index finger, or alternatively a rotary mixer may be used.
  3. Swirl the ampoule gently to return content to the bottom. Allow bubbles to rise before opening.
  4. The Standard(s) should be used in the same way as the samples to be analysed.
  5. Immediate after Use the Standard(s) should be stored at 2-8°C.

Performance characteristics

  1. The haemoglobin Standard Set is designed for Use with the manual methods haemi-globincyanide (cyanmethaemoglobin) or the "alkaline haematine D-575" method.
  2. Automated and semi-automated haematology cell analysers should be calibrated with human whole blood samples using the obtained values of the manual methods as target values.

Warning

Each individual blood-donation intended for Use in manufacturing Haemoglobin Standards
was tested for Hepatitis B surface Antigen (HBsAg), Hepatitis C Virus (HCV) and anti HIV by
FDA required tests. Only individual blood-donations with negative findings were used for the
manufacturing of Haemoglobin Standards. Nevertheless every product obtained from human
body fluids should be considered infectious.


 
  © 2006-2012 by Guenter Keul GmbH - www.keul.de  
Duales System interseroh  
DIN EN ISO 13485:2003
EN ISO 13485:2003