GENETIC TESTS - OTHER
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 08800069800014
- Basic UDI-DI Code
- B-08800069800014
- Reference
- SS-5030
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SEASUN BIOMATERIALS Inc.
Additional Description
U-TOP™ MSI Detection Kit is a real-time PCR based in vitro diagnostic medical device (IVD) intended for the qualitative detection of nucleotide deletions in five mononucleotide Microsatellite Instability (MSI) markers (NR21, NR24, NR27, BAT25, and BAT26) using genomic DNA (gDNA) pairs extracted from matched normal and tumor formalin-fixed paraffin-embedded (FFPE) tissue samples. The kit is intended for use in patients with hereditary colorectal cancer or those with gastric, endometrial or ovarian cancer.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).