Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
VIROLOGY - NA REAGENTS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06930317802094
- Basic UDI-DI Code
- B-06930317802094
- Reference
- DNK-2115-1
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
Additional Description
The Monkeypox Virus Real-time PCR Kit is a multiplex polymerase chain reaction (PCR) in vitro diagnostic (IVD) test for the detection of Monkeypox Virus DNA extracted from serum and lesion exudate sample. This kit established a method that can detect Monkeypox Virus. This method has high sensitivity and specificity, which is of great significance for the early diagnosis and treatment of Monkeypox Virus infections.
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