Basic Information
- Primary DI
- D-5713915PP004TKNU
- Basic UDI-DI Code
- B-5713915PP004TKNU
- Reference
- 1500; 1501; 1848; 1849; 1850
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- PentaBase A/S
Additional Description
PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for in vitro diagnosis of the genomic DNA (gDNA) change giving rise to leucine to proline mutation in codon 265 (L265P) of the Myeloid differentiation primary response 88 (MYD88). Samples shall be obtained from Formalin-Fixed Paraffin-Embedded (FFPE) tissue or blood samples. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. The obtained results of PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay are intended for identification of the presence of the MYD88 L265P, facilitating discrimination between Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM) and non-Hodgkin lymphoma.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01060299 | TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER |
Similar Devices
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