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ACCURUN 146 CMV IgM Positive Control
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref 2015-0088
Identity
- Trade Name
- ACCURUN 146 CMV IgM Positive Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Cytomegalovirus (CMV) antigen IVD, control FDA UDI
- Device Name
- ACCURUN 146 CMV IgM Positive Control EUDAMEDACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL FDA UDI
- Model / Reference
- 2015-0088 EUDAMEDFDA UDI
- Description
- ACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL FDA UDI
Identifiers
- Catalog Number
- 2015-0088 FDA UDI
- Primary DI / UDI-DI
- 00816784020444 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020444 EUDAMED
- 510(k) Number
- K972884 FDA UDI
- FDA Product Code
- LKQ FDA UDI
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Cytomegalovirus (CMV) antigen IVD, control FDA UDI
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3175 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ACCURUN 146 CMV 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-00816784020444 | 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 4c583daf-5cad-4248-ad1b-549b347b1be2 61 fields · synced Jun 19, 2026
- FDA UDI afa16938-db19-4b24-b40b-8236b395bbb7 36 fields · synced May 30, 2026