Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
SHIGELLA - NA REAGENTS
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800204300287
- Basic UDI-DI Code
- B-08800204300287
- Reference
- RB005
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- KH Medical Co., Ltd.
Additional Description
The RADI Shigella spp Detection KIT is an in vitro diagnostic medical device, based on Real-time RT-PCR technology to detect the Shigella spp DNA. The kit is intended for the presumptive qualitative detection of nucleic acid extracted from the Shigella spp e in stool specimens obtained from patients with signs and symptoms of gastroenteritis. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011614 | SHIGELLA - NA REAGENTS |
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