Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇺🇸 United States
Multichem ID ToRCH IgG Negative Control
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00850041090016
- Basic UDI-DI Code
- B-00850041090016
- Reference
- 2010-0023
- 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 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 |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).
master diagnostica
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·VITRO, S.A.·On the market
Vitamin B1 & B6 Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Methylmalonic Acid Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Cortisol & Cortisone Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Vitamin A & E Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Metanephrines Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market