Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
LEISHMANIA
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800204300263
- Basic UDI-DI Code
- B-08800204300263
- Reference
- RB003
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- KH Medical Co., Ltd.
Additional Description
The RADI Kala-azar (Leishmania) Detection Kit is an in vitro diagnostic medical device, based on Real-time RT-PCR technology to detect the Kala-azar (Leishmania) DNA. The kit is intended for the presumptive qualitative detection of nucleic acid extracted from the Kala-azar (Leishmania) in human blood or bone marrow samples. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105050205 | LEISHMANIA |
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