XANTHOCHROMIA POSITIVE CONTROL
(XANTHOCHROMIA )
CATALOGUE NO. XN10505 LOT NOS. 249CF
SIZE: 6 x 4 ml EXPIRY: 2025-05-28
PRESENTATION: Liquid GTIN: 05055273218725
INTENDED USE
The Xanthochromia Positive Control is intended for use with in vitro diagnostic assays for the quantitative determination of Bilirubin
and Oxyhaemoglobin for monitoring of Subarachnoid-haemorrhage testing in Cerebrospinal Fluid (CSF) for Xanthochromia using a
spectrophotometer. Xanthochromia Positive Control is unassayed, without target values and is suitable for use on various UV
spectrophotometer analysers.
Xanthochromia Positive Control is for use by trained laboratory professionals and can be used in determining the precision of testing
systems and in identifying sources of variation.
CHARACTERISTICS
Xanthochromia Positive Control is aqueous based with components of human origin.
STORAGE AND STABILITY
OPENED: Store refrigerated (+2°C to +8°C). Once opened the Xanthochromia Positive Control is stable for 2 days at +2°C to
+8°C, if kept capped in the original container and free from contamination. Only the required amount of product
should be removed. After use, any residual product should NOT BE RETURNED to the original vial.
Aliquoted and frozen immediately at -70°C to -80°C or -18°C to -24°C it can be used up to 28 days single use.
UNOPENED: Store frozen at -70°C to -80°C. Stable to expiration date printed on individual bottles.
If -70°C to -80°C storage is not available, the product may be stored unopened and frozen at -18°C to -24°C. Stable
for a maximum of 11 weeks or until the expiration date, whichever is sooner.
PREPARATION FOR USE
The Xanthochromia Positive Control is supplied liquid frozen. Allow the product to thaw completely at room temperature (+15°C to
+25°C) prior to use. Gently mix the contents of each vial before sampling to ensure homogeneity. Do not shake. After use, replace cap
immediately and store at +2°C to +8°C. Prior to reuse, mix contents thoroughly.
SAFETY PRECAUTIONS AND WARNINGS
For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.
Labelling according to Regulation (EC) No. 1272/2008 [CLP]
Pictogram
Warning
Hazard statement(s)
H317 May cause an allergic skin reaction.
Precautionary statement(s)
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P272 Contaminated work clothing should not be allowed out of the workplace.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P302+P352 If on skin: Wash with plenty of water.
P333+P313 If skin irritation or rash occurs: Get medical advice/attention.
P501 Dispose of contents/container according to local and national guidelines.
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
NONREACTIVE.
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.
Safety Data Sheets are available on request.
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XN10505 – LOT NO. 249CF
MATERIALS PROVIDED
Xanthochromia Positive Control 6 x 4 ml
MATERIALS REQUIRED BUT NOT PROVIDED
Not Applicable
VALUE ASSIGNMENT
Values should be assigned by each laboratory.
26 Nov ’24 me
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