Maxwell® CSC RNA FFPE Kit
Instructions for Use of Product(s)
Literature # TM404
The Maxwell® CSC RNA 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 RNA FFPE Kit is intended for use, in combination with the Maxwell® CSC Instrument and the Maxwell® CSC FFPE RNA purification method, as an in vitro diagnostic (IVD) medical device to perform automated isolation of RNA from human breast, lung and colon FFPE (formalin-fixed, paraffin-embedded) tissue samples. The purified DNA is suitable for use in amplification-based in vitro diagnostic assays.
The Maxwell® CSC RNA FFPE kit is intended to be used at a temperature between 15–30°C. Use outside of this temperature range may result in suboptimal results.
FFPE samples prepared using 10% neutral-buffered formalin can be used with the Maxwell® CSC RNA FFPE Kit. The Maxwell® CSC RNA FFPE Kit is not intended for use as part of a specific diagnostic test. The Maxwell® CSC RNA FFPE Kit is intended for professional use only. Diagnostic results obtained using the RNA purified with this system must be interpreted in conjunction with other clinical or laboratory data.
Summary of Changes
The following change was made to the 8/19 revision of this document:
1. Updated cartridge information in Figure 1.
2. Updated information about the Maxwell® CSC Instrument run in Section 6.
3. Added Section 10, Related Products.
Printed in USA. Revised 8/19.