Eu Ivdr
Eu Ivd Class A
Not Intended For Eu Market
🇨🇳 China
GENEDIAN
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06934244500122
- Basic UDI-DI Code
- 69342445IA001FH
- Reference
- P112-00096
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- Not Intended For Eu Market
- Manufacturer
- Hangzhou DIAN Biotechnology Co., Ltd.
Additional Description
The system is based on the principle of real-time fluorescent PCR detection and is used together with matching nucleic acid detection reagents. It applies clinically for qualitative and quantitative detection of target nucleic acid samples (RNA/DNA) derived from human samples. The Instruments intended by the manufacturer specifically to be used for in vitro diagnostic procedures.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02050201 | MICRO-ARRAY ANALYSERS |
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