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
- 06959094206130
- Basic UDI-DI Code
- B-06959094206130
- Reference
- 8.01.0172
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx ® NRAS Mutation Detection Kit is a real-time PCR assay for qualitative detection of 16 somatic mutations in codons 12, 13, 59, 61, 117 and 146 of NRAS gene in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue. The kit is intended to assess 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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