Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
COVID-19 Coronavirus and Influenza A/B Virus Real Time PCR Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-JC10310NW-25TNW
- Basic UDI-DI Code
- B-JC10310NW-25TNW
- Reference
- JC10310NW-25T
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
Additional Description
COVID-19 Coronavirus and Influenza A/B virus Real Time PCR Kit is an in vitro diagnostic (IVD) reagent replying on fluorescent PCR technology and aiming at qualitatively detection and differentiation of RNA from SARS-CoV-2, influenza A virus, and/or influenza B virus from human upper and lower respiratory tract samples. Upper and lower respiratory tract samples include throat swab and sputum.
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