Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06930317801875
- Basic UDI-DI Code
- B-06930317801875
- Reference
- DNK-2106-1
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
Additional Description
Novel Coronavirus (2019-nCoV) RT-PCR Kit is a polymerase chain reaction IVD test to detect RNA of 2019-nCoV in samples like saliva. These samples were taken from human patients which were considered at risk for the novel coronavirus pneumonia. This assay is used to be an adjunctive diagnostic of COVID-19. It is for professional use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
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