Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇺🇸 United States
ACCURUN 140 Rubella IgG Positive Control
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020413
- Basic UDI-DI Code
- B-00816784020413
- Reference
- 2015-0084
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
ACCURUN® 140 Rubella IgG Positive Control is formulated for use as an unassayed control with in vitro diagnostic test kits for the qualitative determination of IgG antibodies to Rubella virus.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080804 | OTHER VIROLOGY CONTROLS - INF.IMM. |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 575325 | BSI Group The Netherlands B.V. | Expired |
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