Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974677690298
- Basic UDI-DI Code
- B-06974677690298
- Reference
- ZC-HX-203-1
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shanghai BioGerm Medical Technology Co., Ltd.
Additional Description
This kit is used for in vitro qualitative detection of SARS-CoV-2 ORF1ab gene and N gene in oropharyngeal swabs specimens from SARS-CoV2 suspected cases, suspected clustered cases, and others who need to be diagnosed or differentiated
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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