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ACCURUN Babesia Molecular Controls Kit
EUDAMEDFDA UDIClass B (EU MDR)
Ref 2020-0155
Identity
- Trade Name
- ACCURUN Babesia Molecular Controls Kit EUDAMEDACCURUN® FDA UDI
- Generic Name
- Babesia microti nucleic acid IVD, control FDA UDI
- Device Name
- ACCURUN Babesia Molecular Controls Kit EUDAMEDFDA UDI
- Model / Reference
- 2020-0155 EUDAMEDFDA UDI
- Description
- ACCURUN Babesia Molecular Controls Kit FDA UDI
Identifiers
- Catalog Number
- 2020-0155 FDA UDI
- Primary DI / UDI-DI
- 00850041090047 EUDAMEDFDA UDI
- Basic UDI-DI
- 0816784020062XX EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W0105080805 PARASITOLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Babesia microti nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
New Device
Yes
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 Babesia Molecular Controls Kit by LGC Clinical Diagnostics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0816784020062XX | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class 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 a62e3bf1-90aa-4027-a17c-d410a4e3695b 61 fields · synced Jun 18, 2026
- FDA UDI c5438eb1-6baa-4359-a225-3e9430148ae2 34 fields · synced May 30, 2026