Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇺🇸 United States
ACCURUN 800 ToRCH Negative Control
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020239
- Basic UDI-DI Code
- B-00816784020239
- Reference
- 2010-0018
- 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® 800 ToRCH Negative Control is formulated for use with in vitro diagnostic test kits for the detection of IgG and IgM antibodies to Toxoplasma gondii, Rubella virus, Cytomegalovirus, and Herpes Simplex virus.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080899 | CONTROLS - INF. IMMUNOLOGY - OTHER |
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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