Identity
- Trade Name
- A1 Negative Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Negative control immunoglobulin IVD FDA UDI
- Device Name
- A1 Negative Control EUDAMEDACCURUN 1 Multi-Marker Negative Control 12 x 3.5 mL FDA UDI
- Model / Reference
- 2010-0015 EUDAMEDFDA UDI
- Description
- ACCURUN 1 Multi-Marker Negative Control 12 x 3.5 mL FDA UDI
Identifiers
- Catalog Number
- 2010-0015 FDA UDI
- Primary DI / UDI-DI
- 00816784020222 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816784020222 EUDAMED
- FDA Product Code
- KSF FDA UDI
- EMDN Code
- W0105080899 CONTROLS - INF. IMMUNOLOGY - OTHER EUDAMED
- GMDN Term
- Negative control immunoglobulin IVD 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
Dimensions & Sizes
- Size
- Total Volume — 42 Milliliter FDA UDI
A1 Negative Control 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-00816784020222 | 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 8c06d2fc-7ca0-4acd-8d5c-209ae0f0ca9d 61 fields · synced Jun 19, 2026
- FDA UDI f8c1bcad-94f4-44fd-89ca-232d180a9e84 37 fields · synced May 27, 2026