Biochrom Anthos Fluido-2 Microplate Washer v2.0 Page 76
12 Intended Use
This device is intended to be used to remove non-bound sample-sera or to
remove reagents from 96-well respectively 384-well microplates or
format-identical strips. By means of repeated liquid exchange down to a
defined minimum rest volume, for which the sample-/reagent-liquid is
aspirated from the wells into a "waste"-bottle and the wash liquid is
dispensed from stock-("wash-")bottles into the wells of the microplate, the
concentration of the sample shall be diluted until no diagnostically-
relevant rest remains.
The main field of use is ELISA-testing operated and carried out by trained
specialist stuff (medical and/or laboratory).
The Fluido 2 microplate washer has been designed to meet the 98/79/EC
directive of the EU for in-vitro diagnostic devices.
12.1 Quality control
The quality control criteria of a diagnostic kit have to be described in the
package insert of the kit. For the performance of any reagent quality
control it has to be referred exclusively to those instructions.
It is the user's responsibility to ensure proper operation according to the
instructions given with each individual test!
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