Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06959094210601
- Basic UDI-DI Code
- B-06959094210601
- Reference
- 8.01.0001
- 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 Mutation Detection Kit is a real-time PCR assay for qualitative detection of 19 somatic mutations in codons 12, 13, 59, 61, 117 and 146 of KRAS gene in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue. The kit is intended to assess KRAS 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 |
|---|---|
| W01060202 | K-RAS |
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