Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
ACCURUN117 Hepatitis B e Antigen Positive Control
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020291
- Basic UDI-DI Code
- B-00816784020291
- Reference
- 2015-0071
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN® 117 Hepatitis B e Antigen Positive Control has been formulated for use with in vitro diagnostic test kits for the qualitative determination of Hepatitis B e Antigen (HBeAg).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080802 | HEPATITIS VIRUS CONTROLS - INF.IMM. |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 572688 | BSI Group The Netherlands B.V. | Expired |
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