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
- 06959094210809
- Basic UDI-DI Code
- B-06959094210809
- Reference
- 8.01.0246
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The AmoyDx ® Pan Lung Cancer PCR Panel is a real-time PCR assay for qualitative detection of 167 hotspot alterations in EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2 and NTRK3 genes. The kit is intended to be used to aid clinician to identify multi- gene status for NSCLC 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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