Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Rapid HEV IgG/IgM Combo Test Card
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06921963717115
- Basic UDI-DI Code
- B-06921963717115
- Reference
- 1H26C2
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
Additional Description
Rapid HEV IgG/IgM Combo Test Card is a single use, rapid device intended for qualitative detection of IgG-class and IgM-class antibodies to hepatitis E virus (HEV) in serum, plasma or whole blood samples. It is intended to be used in clinical laboratories for diagnosis of acute hepatitis E and management of patients related to infection with hepatitis E virus.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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