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ACCURUN117 Hepatitis B e Antigen Positive Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2015-0071
Identity
- Trade Name
- ACCURUN117 Hepatitis B e Antigen Positive Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Hepatitis B virus e-antigen IVD, control FDA UDI
- Device Name
- ACCURUN117 Hepatitis B e Antigen Positive Control EUDAMEDACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL FDA UDI
- Model / Reference
- 2015-0071 EUDAMEDFDA UDI
- Description
- ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL FDA UDI
Identifiers
- Catalog Number
- 2015-0071 FDA UDI
- Primary DI / UDI-DI
- 00816784020291 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020291 EUDAMED
- 510(k) Number
- K972048 FDA UDI
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0105080802 HEPATITIS VIRUS CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Hepatitis B virus e-antigen IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
ACCURUN117 Hepatitis B e Antigen 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-00816784020291 | 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 98d61af8-d234-419b-aa5d-08919eee86a5 61 fields · synced Jul 18, 2026
- FDA UDI a8bdc4ab-0175-4c77-a3a0-d6a9fe31657d 36 fields · synced May 29, 2026