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Legionella Species Test Kit
EUDAMEDFDA UDIClass B (EU MDR)
Ref DR0803M
by Oxoid Ltd
Identity
- Trade Name
- LEGIONELLA SPECIES TEST KIT EUDAMEDFDA UDI
- Generic Name
- Legionella pneumophila antigen IVD, kit, agglutination FDA UDI
- Device Name
- LEGIONELLA LATEX TEST EUDAMED
- Model / Reference
- DR0803M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384013227 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384LegionAgglutLtxCK EUDAMED
- FDA Product Code
- MJH FDA UDI
- EMDN Code
- W0105010501 LEGIONELLA ANTIGEN DETECTION EUDAMED
- GMDN Term
- Legionella pneumophila antigen IVD, kit, agglutination 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
No
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
Legionella Species Test Kit 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 | 5032384LegionAgglutLtxCK | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 10a6d9b2-1851-42bc-9b90-9bc8d6d8dbc5 61 fields · synced Jun 18, 2026
- FDA UDI 170d75c2-ea65-4389-9c66-e70b932886bb 32 fields · synced May 30, 2026