Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2 Antigen Test Cassette(Nasal Swab Specimen)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06970895474009
- Basic UDI-DI Code
- B-06970895474009
- Reference
- R220T001B0C0
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
The SARS-CoV-2 Antigen Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens in nasal swab specimens from human. The test is intended to aid in the rapid differential diagnosis of SARS-CoV-2 viral infection. The components included in the kit are: 20 Test cassette, 20 extraction buffer, 20 disposable swab, 1 instructions for use and 1 extraction tube with dropping tip, 1 workstation
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040618 | BOCAVIRUS |
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