Maxwell® 16 IVD Instrument Operating Manual
Instructions for Use of Product(s)
Literature # TM315
This product is only available in certain European countries and Canada.
The Maxwell® 16 IVD Instrument is intended for use as an IVD accessory, when used in the IVD mode with the Maxwell® 16 Blood DNA Purification System (Cat.# AS1015) or the Maxwell® 16 Viral Total Nucleic Acid Purification System (Cat.# AS1155). The instrument is used in combination with the Maxwell® 16 Blood DNA Purification System (Cat.# AS1015) to perform automated isolation of genomic DNA from human whole blood or buffy coat samples. Samples collected in blood collection tubes treated with EDTA, heparin or citrate can be used. The instrument is used in combination with the Maxwell® 16 Viral Total Nucleic Acid Purification System (Cat.# AS1155) to perform automated isolation of viral total nucleic acid from human plasma or serum samples.
The nucleic acid isolated using the Maxwell® 16 IVD Instrument is 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 IVD Instrument is not intended for use as part of a specific in vitro diagnostic test. The Maxwell® 16 IVD Instrument is intended for professional use only. Diagnostic results obtained using nucleic acid purified with this system must be interpreted in conjunction with other clinical or laboratory data.
The Maxwell® 16 IVD Instrument is intended for use in the following countries only: Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.
Summary of Changes:
The following change were made to the 4/15 revision of this document:
Figure 7 was updated to correct labeling of the back and front of the Magnetic Rod Assembly.
Printed in USA Revised 4/15.