Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇺🇸 United States
ACCURUN 26 ToRC IgM Positive Control Series 5000
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020147
- Basic UDI-DI Code
- B-00816784020147
- Reference
- 2000-0035
- 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® 26 ToRC IgM Positive Control Series 5000 is formulated for use with in vitro diagnostic test kits for the qualitative detection of IgM antibodies to Toxoplasma gondii, Rubella virus, and Cytomegalovirus (CMV).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080804 | OTHER VIROLOGY CONTROLS - INF.IMM. |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 575325 | BSI Group The Netherlands B.V. | Expired |
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