Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇺🇸 United States
Multichem ID ToRCH IgG Positive Control
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00850041090009
- Basic UDI-DI Code
- B-00850041090009
- Reference
- 2000-0101
- 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
Multichem ID ToRCH IgG Positive Control is formulated for use with in vitro diagnostic test kits for the qualitative determination of IgG antibodies to Toxoplasma gondii, Rubella virus, Cytomegalovirus (CMV) and Herpes Simplex Virus (HSV). This product is not intended for use in testing blood or plasma donors.
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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