TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Basic Information
- Primary DI
- 06959094210274
- Basic UDI-DI Code
- B-06959094210274
- Reference
- 8.06.0115
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx® HRD Complete Panel is HRD Complete 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 homozygous deletions (HD) in protein coding regions and intron/exon boundaries of the following 20 homologous recombination repair (HRR) genes: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CDK12, CHEK1, CHEK2, FANCA, FANCL, HDAC2, PALB2, PPP2R2A, PTEN, RAD51B, RAD51C, RAD51D, RAD54L, TP53, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. The target regions are listed in Appendix Table S1. The assay is intended to aid in identifying prostate cancer patients with pathogenic, or likely pathogenic variants. This assay is not automated and is for laboratory professional use only.
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).