Literature # TM373
The Maxwell® CSC Instrument is available in the United States Only.
The Maxwell® CSC Instrument is intended for use, in combination with Maxwell® CSC reagent kits, as an in vitro diagnostic (IVD) medical device to perform automated isolation of nucleic acids. The nucleic acid isolated using the Maxwell® CSC 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® CSC Instrument is not intended for use as part of a specific in vitro diagnostic test. The Maxwell® CSC Instrument is intended for professional use only. Diagnostic results obtained using the nucleic acids purified with this system must be interpreted in conjunction with other clinical or laboratory data.
The Maxwell® CSC Instrument is not intended for use with reagent kits other than Maxwell® CSC reagent kits or with samples other than those defined within the intended use and product limitations of the specific Maxwell® CSC reagent kit being used.
The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids purified using the Maxwell® CSC Instrument.