← Back to catalogue
Dryspot Legionella Pneumophila 2-14
EUDAMEDFDA UDIClass B (EU MDR)
Ref DR0210M
by Oxoid Ltd
Identity
- Trade Name
- DRYSPOT LEGIONELLA PNEUMOPHILA 2-14 EUDAMEDNA FDA UDI
- Generic Name
- Legionella pneumophila antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- DRYSPOT LEGIONELLA EUDAMED
- Model / Reference
- DR0210M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384060542 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384DSLegionellaXZ EUDAMED
- FDA Product Code
- MJH FDA UDI
- EMDN Code
- W0105010501 LEGIONELLA ANTIGEN DETECTION EUDAMED
- GMDN Term
- Legionella pneumophila antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3300 FDA UDI
- Market of Registration
- Netherlands 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
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
Dryspot Legionella Pneumophila 2-14 by Oxoid Ltd — 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 | 5032384DSLegionellaXZ | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED b25f59b6-cab6-432c-b266-a6a3199c2b54 61 fields · synced Aug 3, 2026
- FDA UDI 1e6f5c2e-e17d-48b9-b76b-dbcda0b16f05 33 fields · synced May 30, 2026