Identity
- Trade Name
- O.B.I.S CAMPY KIT EUDAMEDOBIS CAMPY KIT FDA UDI
- Generic Name
- Multiple Campylobacter species antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- O.B.I.S CAMPY KIT EUDAMED
- Model / Reference
- ID0800M EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384167746 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384OBISCampyPB EUDAMED
- FDA Product Code
- LIB FDA UDI
- EMDN Code
- W0104080201 GRAM NEGATIVE - MANUAL IDENTIFICATION EUDAMED
- GMDN Term
- Multiple Campylobacter species antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 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
No
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
O.b.i.s Campy Kit by Oxoid Ltd — Class A — 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 | 5032384OBISCampyPB | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 406ae50c-f002-43ed-af14-420039d471f4 61 fields · synced Jul 20, 2026
- FDA UDI 2177b512-9952-4e57-9330-857c358df3e7 32 fields · synced May 30, 2026