Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇨🇳 China
CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06935091671904
- Basic UDI-DI Code
- B-06935091671904
- Reference
- /
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Qingdao Hightop Biotech Co., Ltd.
Additional Description
The reagent is used for in vitro qualitative detection of CMV IgM antibody in human serum/plasma /whole blood, suitable for auxiliary diagnosis of CMV recent and the epidemiological investigation of CMV infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099001 | CMV - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | W0105099001 | TÜV SÜD Product Service GmbH | Expired |
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