Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Monkeypox Virus Typing Nucleic Acid Detection Kit (Fluorescence PCR)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-00001280719907AT2
- Basic UDI-DI Code
- B-00001280719907AT2
- Reference
- HWTS-OT201
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Additional Description
This kit is used for in vitro qualitative detection of monkeypox virus clade I, clade II nucleic acids human rash fluid, throat swabs and serum samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040599 | VIROLOGY - NA REAGENTS - OTHER |
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