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Multichem ID Rubella IgM Positive Control
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref 2015-0240
Identity
- Trade Name
- Multichem ID Rubella IgM Positive Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Multiple infectious organism/newborn TORCH screen IVD, control FDA UDI
- Device Name
- Multichem ID Rubella IgM Positive Control EUDAMED
- Model / Reference
- 2015-0240 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850041090023 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850041090023 EUDAMED
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple infectious organism/newborn TORCH screen IVD, control FDA UDI
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Multichem ID Rubella IgM Positive Control by LGC Clinical Diagnostics, Inc. — Class IVD Annex II List B — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00850041090023 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | Pending data |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED b42896cc-d926-41c9-a865-4e6b3cd67250 61 fields · synced Jul 18, 2026
- FDA UDI 4df15f6a-78e1-4ed6-bcdd-b2a834610207 32 fields · synced May 30, 2026