Identity
- Trade Name
- A1 Negative Control EUDAMEDACCURUN® FDA UDI
- Generic Name
- Hepatitis B virus antigen/antibody marker IVD, control FDA UDINegative control immunoglobulin IVD FDA UDI
- Device Name
- A1 Negative Control EUDAMEDACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL FDA UDI
- Model / Reference
- 2010-0013 EUDAMEDFDA UDI2000-0071 FDA UDI
- Description
- ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL FDA UDI
Identifiers
- Catalog Number
- 2010-0013 FDA UDI
- Primary DI / UDI-DI
- 00816784021007 EUDAMEDFDA UDI00816784020215 FDA UDI
- Basic UDI-DI
- B-00816784021007 EUDAMED
- FDA Product Code
- KSF FDA UDI
- EMDN Code
- W0105080899 CONTROLS - INF. IMMUNOLOGY - OTHER EUDAMED
- GMDN Term
- Hepatitis B virus antigen/antibody marker IVD, control FDA UDINegative 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
Yes
FDA UDIFDA 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
Yes
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 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-00816784021007 | 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 (3)
- EUDAMED 8d06f83c-099a-4fe8-9d79-3c6f8163ad09 61 fields · synced Jun 18, 2026
- FDA UDI b7f72945-49ef-4dd2-903e-20e01a52c03f 32 fields · synced May 30, 2026
- FDA UDI 545fe54a-7e4e-4959-b1ed-f31a503eb6cc 37 fields · synced May 30, 2026