Maxwell® CSC Blood DNA Kit
Instructions for Use of Product(s)
Literature # TM374
The Maxwell® CSC Blood DNA Kit is for sale only in Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Korea, Luxembourg, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom and United States.
The Maxwell® CSC Blood DNA Kit is intended for use, in combination with the Maxwell® CSC Instrument and the Maxwell® CSC Blood DNA purification method, as an in vitro diagnostic (IVD) medical device to perform automated isolation of genomic DNA from human whole blood samples. The Maxwell® CSC Instrument is supplied with preprogrammed purification methods and is designed for use with the predispensed reagent cartridges and additional reagents supplied in the kit. The purified DNA is suitable for use in amplification-based in vitro diagnostic assays. Whole blood samples collected in blood collection tubes containing EDTA, heparin or sodium citrate anticoagulants can be used with the Maxwell® CSC Blood DNA Kit. The Maxwell® CSC Blood DNA Kit is not intended for use as part of a specific diagnostic test. The Maxwell® CSC Blood DNA Kit is intended for professional use only. Diagnostic results obtained using the genomic DNA purified with this system must be interpreted in conjunction with other clinical or laboratory data.
The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using genomic DNA purified using the Maxwell® CSC Blood DNA Kit.
Summary of Changes
The following change was made to the 5/18 revision of this document:
1. Updated to include EU IVD Directive (98/79/EC) requirements.