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ACCURUN 25 ToRCH IgG Positive Control S2000
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 2000-0074
Identity
- Trade Name
- ACCURUN 25 ToRCH IgG Positive Control S2000 EUDAMED
- Device Name
- ACCURUN 25 ToRCH IgG Positive Control S2000 EUDAMED
- Model / Reference
- 2000-0074 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816784020727 EUDAMED
- Basic UDI-DI
- B-00816784020727 EUDAMED
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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 25 ToRCH IgG Positive Control S2000 by LGC Clinical Diagnostics, Inc. — Class IVD Annex II List B — 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-00816784020727 | Class IVD Annex II List B | 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 0fd47d82-4c8a-4a67-94ce-b2f6bf807fc6 61 fields · synced Jul 12, 2026