Maxwell Clinical Instrument Manual AS2050

Instructions for Use of Product(s)

Literature # TM300

This system, including the Maxwell® 16 Clinical Instrument (Cat.# AS2050), has been discontinued.

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 System is intended for professional use only. Diagnostic results obtained using DNA purified with this system must be interpreted in conjunction with other clinical or laboratory data.

2/08.

Complete Protocol
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