Produkte/Klinische Chemie/Kontrollen/Kontrollseren/Tumor Maker Control

Tumor Maker Control

quality control for clinical chemistry and immunoassay systems

available in two levels

LevelSizeCat. No.
23 x 2 mlKG5002
33 x 2 mlKG5003

 

INTENDED USE
This product is intended for in-vitro diagnostic use in the quality control of diagnostic assays on clinical chemistry and immunoassay systems. The Tumour Marker Controls are for the control of accuracy and reproducibility.

DEVICE DESCRIPTION
The Tumour Marker Controls are supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for tumour markers as listed in the value tables for both levels.

SAFETY PRECAUTIONS AND WARNINGS
For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.
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.
Health and Safety Data Sheets are available on request.

STORAGE AND STABILITY
OPENED: Store refrigerated (+2°C to +8°C). Once reconstituted, Tumour Marker Controls are stable for 14 days when stored tightly capped at +2°C to +8°C in the absence of contamination, with the following exceptions: Total PSA and Free PSA are stable for 7 days. Thyroglobulin and Calcitonin should be assayed immediately following reconstitution. No claim is made for the stability of CA 72-4, Calcitonin, Cyfra 21 and NSE. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial.
UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

PREPARATION FOR USE
Open the vial carefully, avoiding any loss of the material and reconstitute with 2ml of distilled water. Replace the rubber stopper, close the vial and leave to stand for 30 minutes before use. Ensure that all traces of dry material are dissolved by swirling gently.

MATERIALS PROVIDED
Tumour Marker Control Level 2    3 x 2ml
Tumour Marker Control Level 3    3 x 2ml

ASSIGNED VALUES
Each batch of Tumour Marker Controls is submitted to a number of external laboratories and values are assigned from a consensus of results obtained by these laboratories. With each batch a control range is provided for individual parameters and each parameter method.


img/page/needfull/Tabelle-unten1.jpg

 

 

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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