MONOGENETIC DISORDERS TESTS - OTHER
Basic Information
- Primary DI
- D-9021B6
- Basic UDI-DI Code
- B-9021B6
- Reference
- RC-PALB096-I
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- NimaGen BV
Additional Description
The intended purpose of this assay is NGS library preparation for Illuminaยฎ sequencing of the human PALB2 gene exons including a minimum of 20 bases upstream and downstream of each exon; to aid in diagnosis of congenital predisposition to cancer by detecting sequence variants. The assay is designed for use with is DNA extracted from peripheral blood. Specimens should have an absorbance ratio (260/280) of ~1.8, regardless of the extraction method used. The assay provides reagents for Multiplex Amplicon based NGS library preparation and is for professional use only. The kit is based on the patented Reverse Complement PCR technology, providing a safe, robust and simple workflow, combining multiplex amplification a single reaction, decreasing risk for PCR contamination and sample swapping.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010199 | MONOGENETIC DISORDERS TESTS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).