TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Primary DI

06959094212384

Basic UDI-DI Code

B-06959094212384

Reference

8.0680701X024I

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Amoy Diagnostics Co., LTD.

The AmoyDx® HANDLE HRR NGS Panel (Reversible Terminator Sequencing) is intended for qualitative detection of single nucleotide variants (SNVs) and insertions and deletions (Indels) variants in protein coding regions and intron/exon boundaries of 27 HRR genes (AR, ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CDK12, CHEK1, CHEK2, ESR1, FANCA, FANCL, HDAC2, HOXB13, MRE11, NBN, PALB2, PPP2R2A, PTEN, RAD51B, RAD51C, RAD51D, RAD54L, STK11 and TP53), and SNVs/Indels variants in hotspot regions of 5 driver genes (BRAF, ERBB2, KRAS, NRAS and PIK3CA) using DNA isolated from peripheral whole blood samples, fresh-frozen tumor tissue or formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. In addition, the kit also allows the detection of large rearrangements (LRs) of the BRCA1 and BRCA2 genes from blood-derived DNA. The kit is intended to be used by trained professionals in a laboratory environment.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).