Basic Information
- Primary DI
- D-5713915PP001TDMX
- Basic UDI-DI Code
- B-5713915PP001TDMX
- Reference
- 7032; 7030
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- PentaBase A/S
Additional Description
PlentiPlex™ KIT Mastocytosis qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for in vitro diagnosis of the genomic change giving rise to the aspartic acid to valine mutation in codon 816 of the human KIT proto-oncogene receptor tyrosine kinase (KIT D816V). Samples are genomic DNA (gDNA) purified from blood samples. The obtained results of PlentiPlex™ KIT Mastocytosis qPCR Assay are intended for the identification of the presence and/or quantity of the KIT D816V mutation as part of the World Health Organization (WHO) diagnostic criteria to assist the diagnosis of Mastocytosis. PlentiPlex™ KIT Mastocytosis 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 |
|---|---|
| W01060299 | TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).