Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
A52 Hepatitis Multi-Marker
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020208
- Basic UDI-DI Code
- B-00816784020208
- Reference
- 2000-0043
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN® 52 Multi-Marker Hepatitis Positive Control 2 has been formulated for use with in vitro diagnostic test kits for the qualitative determination of antibodies to Hepatitis B e Antigen (anti-HBe), Hepatitis B Surface Antigen (anti-HBs), and Hepatitis A Virus (anti- HAV).
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 572689 | BSI Group The Netherlands B.V. | Expired |
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