CONTROL PREPARATION its own mean value for this control.

WARNINGS AND PRECAUTIONS

1. The lyophilisate is vacuum sealed, therefore the vial
should be opened very carefully to avoid loss of Each individual blood donation used for production of
dried material. DIACON N Control was found to be non-reactive when
2. Add exactly 5 ml of dist. water (inaccurate tested with approved methods for HbsAg, anti-HIV 1+2
reconstitution of the control and error in assay and anti-HCV. As there is no possibility to exclude
Liquid Reagents – ready to use
technique can cause erroneous results.) definitely that products derived from human blood
3. Close the vial carefully and let the control stand for transmit infectious agents, it is recommended to handle
Lyophilized Serum Control 30 min. the control with the same precautions used for patient
specimens.
4. Dissolve contents completely by swirling gently,
avoiding the formation of foam. Do not shake!
DIACON N CONTROL STABILITY AND STORAGE WASTE MANAGEMENT
(Assayed Universal Control Storage: at 2 – 8°C Please refer to local legal requirements.
Serum Normal) Stability: until date of expiration
Stability after reconstitution:
Single Reagent
20–25°C 2 - 8°C -20°C
Bilirubin (in the dark): - 2 days 14 days
Lyophilized universal control serum for the use in GPT 2 hours 2 days 30 days
tests for the quantitative in vitro determination of GOT 8 hours 2 days 30 days
various analytes on photometric systems. CK-NAC, CK-MB 4 hours 7 days 30 days
Other Analytes: 8 hours 7 days 30 days
CLOSE IMMEDIATELY AFTER USE
Do not use the product if there is visible evidence of
DIA030012 1 x 5 ml DIACON N microbial growth in the vial.
DIA030010 3 x 5 ml DIACON N Improper handling and/or storage of the control can
DIA030011 5 x 5 ml DIACON N affect results. DIAGNOSTICA Products : Rte de Gabes Km 9 Z.I Thyna Al
DIA030014 10x 5 ml DIACON N FREEZE ONLY ONCE! Jadida SFAX TUNISIA
DIA030015 12 x 5 ml DIACON N Phone: 00 216 74 687 940
LOT SPECIFIC ASSAY DATA Fax: 00 216 74 687 932
Values and Expiry Date are LOT specific. E-mail: contact@diagnostica-products.com
COMPOSITION Please refer to table with Lot specific assay data. Web : www.diagnostica-products.com
COMPONENTS: ASSAY VALUES AND RANGES
Pooled human serum
The assay values and ranges provided for each
Purified human and animal components
analyte listed are derived using DIAGNOSTICA reagents
Purified drugs
or reagents from other manufacturers.
Non organic components
Stabilisers It is recommended that each laboratory establishes