Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
GENETIC TESTS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
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 |
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