Basic Information
- Primary DI
- 06959094210519
- Basic UDI-DI Code
- B-06959094210519
- Reference
- 8.06.0104
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx® BRCA Pro Panel is a next-generation sequencing (NGS) based in vitro diagnostic assay intended for qualitative detection and classification of single nucleotide variants (SNVs), insertions and deletions (InDels), and large rearrangements (LRs) in protein coding regions, intron/exon boundaries, some introns and UTR regions of the BRCA1 and BRCA2 genes, using DNA isolated from peripheral whole blood or formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. The detection of large rearrangement deletions and duplications is available for blood-derived DNA only. The assay is intended to aid in identifying breast cancer or ovarian cancer patients with pathogenic, or likely pathogenic BRCA variants. This assay is not automated and is for laboratory professional use only
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01060203 | BRCA 1+2 |
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