Area Of Application; Intended Use - tecan sunrise RC Technical Manual

2.2 Area of Application

2.2.1

Intended Use

2004-10 Technical Manual for sunrise RC, TW, TS, TC, BC, 6F No. T 137 302 Rev No. 1.1
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The Absorbance Reader is an optical 96-well microplate reader for the
measurement of absorbance including turbidimetry (optical density) of samples
from biological or non-biological origin. According to the specifications described
in this manual, the instrument is intended for professional use in:
In-vitro diagnostic environments with tests like:
•
Enzyme Immuno Assays (EIA), e.g. for diagnostic of infectious
diseases, autoimmune diagnostic, allergy screening
•
Agglutination Assays, e.g. for blood typing assays
•
Enzyme Assays, e.g. haemostaseology assays and
•
Enzyme Linked Probe Hybridization Assays (ELPHA), e.g. HLA-
typing assays
which have been validated according to the IVD directive or other
relevant regulations or
Pharmaceutical, biotechnological and life science industry, for research
use, for food analysis and veterinary applications.
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The Absorbance Reader has been validated for use with representative
applications from the above list. The validation shows the general ability of the
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Absorbance Reader to use the above mentioned methods.
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If the
are modified in any way the instrument loses its guarantee
and will no longer be IVD compliant.
The operating authority must use only CE-labeled test kits for clinical
diagnostic applications. The operating authority must assure that the
combination of a particular CE-labeled test kit used with the CE-labeled
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Absorbance Reader has been validated according to the IVD
directive or to other relevant national or local regulations.
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If the Absorbance Reader is used with any other software other than
Magellan, additional validation must be carried out by the operating authority to
ensure the safety of the results. The operating authority is fully responsible for
any results obtained using software other than Magellan with the
Absorbance Reader.
Note
Absorbance Reader or Magellan software
Note
2. General
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2-3