TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 06959094210861
- Basic UDI-DI Code
- B-06959094210861
- Reference
- 8.01.0005
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx® EGFR 29 Mutations Detection Kit is a real-time PCR assay for qualitative detection of 29 somatic mutations in exons 18, 19, 20 and 21 of EGFR gene in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue, or circulating DNA extracted from plasma/serum. The kit is intended to assess EGFR mutation status in NSCLC patients and aid in identifying patients who may respond to the treatment with an EGFR-TKI. The kit is for in vitro diagnostic use, and intended to be used by trained professionals in a laboratory environment.
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).