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ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref 2015-0072Model 2015-0072
Identity
- Trade Name
- ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Hepatitis B virus e-antigen IVD, control FDA UDI
- Device Name
- ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control EUDAMEDACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL FDA UDI
- Model / Reference
- 2015-0072 EUDAMEDFDA UDI
- Description
- ACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL FDA UDI
Identifiers
- Catalog Number
- 2015-0072 FDA UDI
- Primary DI / UDI-DI
- 00816784020307 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020307 EUDAMED
- 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
ACCURUN 119 Anti-Hepatitis B e Antigen (Anti-HBe) Positive Control by LGC Clinical Diagnostics, Inc. — Class IVD General — FDA_510K, IVDD — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972307 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-00816784020307 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (3)
- EUDAMED 7e7b6e31-449b-4f5c-9d6c-6f898c85b7bc 61 fields · synced Oct 5, 2026
- FDA UDI 61b1aca2-da1b-4c13-a006-78ce3880fe21 35 fields · synced May 30, 2026
- FDA 510(k) K972307 1 fields · synced May 18, 2026