Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
๐ณ๐ฑ Netherlands
CMV Brite Turbo kit
Devices (same UDI-DI)
1
Certificates
1
Countries
5
Notified Bodies
1
Basic Information
- Primary DI
- 08717953022301
- Basic UDI-DI Code
- B-08717953022301
- Reference
- VIR-CMV 110
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- IQ Products BV
Additional Description
The CMV Briteโข Turbo kit is intended for the rapid qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect immunofluorescence using microscopy in isolated peripheral blood leukocytes obtained from ethylenediaminetetraacetic acid (EDTA) or heparin anti-coagulated human peripheral blood. The detection of CMV pp65 in human peripheral blood cells aids in the diagnosis of acute or reactivated CMV infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040299 | CMV REAGENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 2114129CE01 | DEKRA Certification B.V. | Expired |
Available In Countries
๐ฉ๐ช Germany
๐ซ๐ท France
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
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