TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
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Basic Information
- Primary DI
- 06959094212483
- Basic UDI-DI Code
- B-06959094212483
- Reference
- 8.01.20213X012E
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Amoy Diagnostics Co., LTD.
Additional Description
The Super-ARMS ® EGFR Mutation Detection Kit is a real-time PCR assay for qualitative detection of 42 somatic mutations in exons 18, 19, 20 and 21 of EGFR gene in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue or ctDNA extracted from plasma sample. The kit is intended to be used to assess EGFR mutation status in NSCLC patients and aid in identifying patients who may respond to treatment with an EGFR-TKI. 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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