Maxwell® CSC DNA FFPE Kit Technical Manual
Instructions for Use of Product(s)
Literature # TM395
The Maxwell® CSC DNA FFPE Kit is for sale only in Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Korea, Luxembourg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom and United States.
The Maxwell® CSC DNA FFPE Kit is intended for use, in combination with the Maxwell® CSC Instrument and the Maxwell® CSC FFPE DNA purification method, as an in vitro diagnostic (IVD) medical device to perform automated isolation of DNA from FFPE (formalin-fixed, paraffin-embedded) tissue samples. The purified DNA is suitable for use in amplification-based in vitro diagnostic assays.
Summary of Changes
The following change was made to the 3/21 revision of this document:
1. Included use instructions for the Maxwell® CSC 48 Instrument.
2. Updated Section 6.
3. Updated Section 10.
4. Updated patent statement.
5. Updated cover page.