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ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000
EUDAMEDClass IVD General (EU MDR)
Ref 2000-0067Model 2000-0067
Identity
- Trade Name
- ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000 EUDAMED
- Device Name
- ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000 EUDAMED
- Model / Reference
- 2000-0067 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816784020949 EUDAMED
- Basic UDI-DI
- B-00816784020949 EUDAMED
- EMDN Code
- W0105080802 HEPATITIS VIRUS CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
ACCURUN 51 Multi-Marker Hepatitis Positive Control 1 Series 3000 by LGC Clinical Diagnostics, Inc. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00816784020949 | 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 (1)
- EUDAMED 37c8304a-0d3f-40c7-bc34-435ccb972f15 61 fields · synced Jul 11, 2026