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ACCURUN 31 EBV IgM Positive Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2000-0038
Identity
- Trade Name
- ACCURUN 31 EBV IgM Positive Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Device Name
- ACCURUN 31 EBV IgM Positive Control EUDAMEDACCURUN 31 EBV IgM 3 x 1.0 mL FDA UDI
- Model / Reference
- 2000-0038 EUDAMEDFDA UDI
- Description
- ACCURUN 31 EBV IgM 3 x 1.0 mL FDA UDI
Identifiers
- Catalog Number
- 2000-0038 FDA UDI
- Primary DI / UDI-DI
- 00816784020161 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020161 EUDAMED
- FDA Product Code
- DGQ FDA UDI
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5700 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ACCURUN 31 EBV IgM Positive Control by LGC Clinical Diagnostics, Inc. — Class IVD General — 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-00816784020161 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 4c80d5be-117d-4dc2-bd04-9e44ee27f54f 61 fields · synced Jul 8, 2026
- FDA UDI 43acaa82-9e61-40a7-9b06-0d72a6786e14 35 fields · synced May 30, 2026