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A113 Anti-HBc IgM
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2015-0068Model 2015-0068
Identity
- Trade Name
- A113 Anti-HBc IgM EUDAMEDACCURUN® FDA UDI
- Generic Name
- Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Device Name
- A113 Anti-HBc IgM EUDAMEDACCURUN 113 Hepatitis B Core IgM 1 x 5.0 mL FDA UDI
- Model / Reference
- 2015-0068 EUDAMEDFDA UDI
- Description
- ACCURUN 113 Hepatitis B Core IgM 1 x 5.0 mL FDA UDI
Identifiers
- Catalog Number
- 2015-0068 FDA UDI
- Primary DI / UDI-DI
- 00816784020277 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020277 EUDAMED
- FDA Product Code
- DGQ FDA UDI
- EMDN Code
- W0105080802 HEPATITIS VIRUS CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Hepatitis B virus core immunoglobulin M (IgM) antibody 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
A113 Anti-HBc IgM 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-00816784020277 | 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 13c7807d-a811-4a45-a66d-30533d665a9e 61 fields · synced Jul 18, 2026
- FDA UDI 0eb5db08-8c29-4ee1-9ac2-fdca8e00085e 35 fields · synced May 30, 2026