Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇺🇸 United States
ACCURUN 135 Toxoplasma IgG Positive Control
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00816784020390
- Basic UDI-DI Code
- B-00816784020390
- Reference
- 2015-0082
- 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® 135 Toxoplasma IgG Positive Control is formulated for use as an unassayed serum control with in vitro diagnostic test kits for the qualitative detection of IgG antibodies to Toxoplasma gondii.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080805 | PARASITOLOGY 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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