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
- 06959094210847
- Basic UDI-DI Code
- B-06959094210847
- Reference
- 8.01.0022
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx ® ROS1 Gene Fusions Detection Kit is a real-time PCR assay for qualitative detection of 14 ROS1 gene fusions in human total RNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissues in NSCLC patients. The kit is intended to assess ROS1 gene status in NSCLC patients and to aid the clinician in identifying NSCLC patients who may response to ROS1 inhibitor therapy. 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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