Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06959094210892
- Basic UDI-DI Code
- B-06959094210892
- Reference
- 8.01.0032
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx ® KRAS/NRAS Mutations Detection Kit is a real-time PCR assay for qualitative detection of 19 KRAS mutations (exons 2, 3 and 4) and 13 NRAS mutations (exons 2, 3 and 4) in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue. The kit is intended to assess KRAS/NRAS mutation status in colorectal cancer patients. 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 |
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