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
- 06975977070506
- Basic UDI-DI Code
- B-06975977070506
- Reference
- 600050
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Probe Diagnostic Biotechnology Inc. MF
Additional Description
The Lung Cancer Mutant Genes Detction Panel is a real-time PCR assay for qualitative detection of 139 hotspot alterations in EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, NTRK3, FGFR1, FGFR2 and FGFR3 genes. The kit is intended to be used to aid clinician to identify multi-gene status for NSCLC patients. The kit is for research use only, 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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