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Abstract for Maxwell® 16 Clinical Instrument Technical Manual
(IVD; Cat.# AS2050)
The Maxwell® 16 System, which consists of the Maxwell® 16
Clinical Instrument (Cat.# AS2050) and the Maxwell® 16 Blood DNA
Purification Kit (Cat.# AS1015), is used to perform automated
isolation of DNA from human whole blood or buffy coat samples.
Samples collected in blood collection tubes treated with EDTA,
heparin or citrate can be used with the Maxwell® 16 System. The
nucleic acid isolation methodology used by the Maxwell® 16 System
produces DNA suitable for direct, downstream analysis by standard
amplification methods. These methods include a variety of polymerase
chain reaction (PCR) tests for human in vitro diagnostic purposes.
The Maxwell® 16 System is not intended for use as part of a specific
in vitro diagnostic test. The Maxwell® 16 Clinical Instrument
displays the CE conformity marking to identify it as fulfilling the
requirements of the Low Voltage Directive, Electromagnetic
Compatibility Directive, and the In Vitro Diagnostic Medical Device
Directive and associated harmonized standards.
The Maxwell® 16 Clinical Instrument Technical Manual is
available in English, French, German, Dutch, Spanish and Portuguese.
Use the links on the left to download the manual in your preferred
language.
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