← Back to catalogue
Accurun 1 S8100 Positive Control
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 2000-0022
Identity
- Trade Name
- Accurun 1 S8100 Positive Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Multiple blood-borne virus antigen/antibody IVD, control FDA UDI
- Device Name
- Accurun 1 S8100 Positive Control EUDAMEDACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL FDA UDI
- Model / Reference
- 2000-0022 EUDAMEDFDA UDI
- Description
- ACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL FDA UDI
Identifiers
- Catalog Number
- 2000-0022 FDA UDI
- Primary DI / UDI-DI
- 00816784020789 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020789 EUDAMED
- FDA Product Code
- KSF FDA UDI
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple blood-borne virus antigen/antibody IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9650 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 1 S8100 Positive Control by LGC Clinical Diagnostics, Inc. — Class IVD General — 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-00816784020789 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 5688458e-3c28-455d-90a9-8808523b8d4d 61 fields · synced Jul 9, 2026
- FDA UDI 899d7415-4e2f-4a94-9351-c2b17bab4b52 36 fields · synced May 29, 2026