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ACCURUN 25 ToRCH IgG Positive Control S5000
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref 2000-0034
Identity
- Trade Name
- ACCURUN 25 ToRCH IgG Positive Control S5000 EUDAMEDACCURUN® FDA UDI
- Generic Name
- Multiple infectious organism/newborn TORCH screen IVD, control FDA UDI
- Device Name
- ACCURUN 25 ToRCH IgG Positive Control S5000 EUDAMEDACCURUN 25 ToRCH IgG Series 5000 3 x 1.0 mL FDA UDI
- Model / Reference
- 2000-0034 EUDAMEDFDA UDI
- Description
- ACCURUN 25 ToRCH IgG Series 5000 3 x 1.0 mL FDA UDI
Identifiers
- Catalog Number
- 2000-0034 FDA UDI
- Primary DI / UDI-DI
- 00816784020130 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020130 EUDAMED
- FDA Product Code
- DGQ FDA UDI
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple infectious organism/newborn TORCH screen IVD, control FDA UDI
Classification
- Device Class
- Class IVD Annex II List B 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
ACCURUN 25 ToRCH IgG Positive Control S5000 by LGC Clinical Diagnostics, Inc. — Class IVD Annex II List B — 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-00816784020130 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | 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 b98855ec-bb49-4bbe-8cae-6fafeb5f42ec 61 fields · synced Jun 19, 2026
- FDA UDI 96a0c1f1-729a-40d4-a6a6-705487c63f17 35 fields · synced May 30, 2026