Identity
- Trade Name
- A1 Series 4400 EUDAMEDACCURUN® FDA UDI
- Generic Name
- Multiple blood-borne virus antigen/antibody IVD, control FDA UDI
- Device Name
- A1 Series 4400 EUDAMEDACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL FDA UDI
- Model / Reference
- 2000-0010 EUDAMEDFDA UDI
- Description
- ACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL FDA UDI
Identifiers
- Catalog Number
- 2000-0010 FDA UDI
- Primary DI / UDI-DI
- 00816784020055 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020055 EUDAMED
- FDA Product Code
- KSF FDA UDI
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple blood-borne virus antigen/antibody IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9650 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
A1 Series 4400 by LGC Clinical Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00816784020055 | 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 39284f18-c188-4f20-97e2-bb68864de1b4 61 fields · synced Jun 18, 2026
- FDA UDI 29a188f0-67ae-49ad-b5e7-12a3789df4b0 36 fields · synced May 30, 2026