Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Monkeypox Virus Fluorescent PCR Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06950617490951
- Basic UDI-DI Code
- B-06950617490951
- Reference
- GN7102110
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Maccura Biotechnology Co., Ltd.
Additional Description
For in vitro qualitative detection of monkeypox virus in human oropharyngeal swabs, nasopharyngeal swab, blood, blister, pustular lesion fluid samples by real-time PCR method. This product is only intended for professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070502 | OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries