Basic Information
- Primary DI
- D-5713915SS005VBRF
- Basic UDI-DI Code
- B-5713915SS005VBRF
- Reference
- 1900;1701;1905;1706;1910;1711;1915;1716;1925;1726;1930;1731;1940;1741;1945;1746;1955;1756;1960;1761
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- PentaBase A/S
Additional Description
SensiScreen® FFPE KRAS qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the semi-quantitative detection of specific somatic KRAS proto-oncogene (KRAS) gene mutations in human DNA purified from solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) tissue. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. SensiScreen® FFPE KRAS qPCR Assay is an in vitro diagnostic medical device intended to detect, identify, and quantify the KRAS somatic mutational status as an aid in selecting proper treatment of cancer. SensiScreen® FFPE KRAS qPCR Assay is intended for use by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01060202 | K-RAS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).