Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
PLASMODIUM (MALARIA)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800204300638
- Basic UDI-DI Code
- B-08800204300638
- Reference
- RB007
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- KH Medical Co., Ltd.
Additional Description
The RADI Malaria Detection KIT is an in vitro diagnostic medical device, based on Real-time RT-PCR technology to detect the Malaria DNA. The kit is intended for the presumptive qualitative detection of nucleic acid extracted from the five human pathogenic species Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae, Plasmodium ovale and Plasmodium knowlesi. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105050209 | PLASMODIUM (MALARIA) |
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