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ACCURUN 125 Anti-HBs Positive Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2015-0078
Identity
- Trade Name
- ACCURUN 125 Anti-HBs Positive Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Hepatitis B virus surface antigen IVD, control FDA UDI
- Device Name
- ACCURUN 125 Anti-HBs Positive Control EUDAMEDACCURUN 125 Anti-HBs 6 x 3.5 mL FDA UDI
- Model / Reference
- 2015-0078 EUDAMEDFDA UDI
- Description
- ACCURUN 125 Anti-HBs 6 x 3.5 mL FDA UDI
Identifiers
- Catalog Number
- 2015-0078 FDA UDI
- Primary DI / UDI-DI
- 00816784020352 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020352 EUDAMED
- FDA Product Code
- DGQ FDA UDI
- EMDN Code
- W0105080802 HEPATITIS VIRUS CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Hepatitis B virus surface antigen 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 125 Anti-HBs 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-00816784020352 | 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 9b05f447-e2e1-4218-a2e6-1ecf98551598 61 fields · synced Jun 18, 2026
- FDA UDI 5a1e989f-c6b4-48cb-9a4d-a77c9e15b6a9 35 fields · synced May 30, 2026