Eu Ivdd
Eu Ivd General
On The Market
🇸🇬 Singapore
Sentosa SA KRAS PCR Test (4x8)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08885013953183
- Basic UDI-DI Code
- B-08885013953183
- Reference
- 300083
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
Additional Description
The Sentosa® SA KRAS PCR Test is used in the detection of seven somatic mutations in codon 12 and 13, and will provide a qualitative assessment of mutation status in DNA samples extracted from colorectal formalin-fixed paraffin-embedded (FFPE) tissue. This test is intended for use on the Sentosa® SX101 nucleic acid extraction platform in conjunction with the Rotor-Gene® Q MDx 5plex HRM platform.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01060299 | TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER |
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