Eu Ivdr
Eu Ivd Class B
On The Market
🇮🇱 Israel
MeMed BV® External Control
Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0
Basic Information
- Primary DI
- 17290018739034
- Basic UDI-DI Code
- 729001873903CY
- Reference
- FG12001
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- MeMed Diagnostics Ltd.
Additional Description
The MeMed BV® External Control is an ancillary intended for qualitative quality control testing of the MeMed BV® test via the MeMed Key® Analyzer. The MeMed BV® External Control contains purified antigens (TRAIL, IP-10 and CRP) in a protein containing buffer in concentrations representing viral and bacterial score and is intended to provide the laboratory professional user with a pass/fail status of the device ability to differentiate viral from bacterial infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021521 | MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS |
Available In Countries
🇧🇪 Belgium
🇩🇪 Germany
🇬🇷 Greece
🇮🇹 Italy
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