Identity
- Trade Name
- IMAGEN CHLAMYDIA KIT EUDAMEDIMAGEN Chlamydia FDA UDI
- Generic Name
- Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- IMAGEN CHLAMYDIA KIT EUDAMED
- Model / Reference
- K610111-2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384502943 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384ImagenChlamydiaW7 EUDAMED
- FDA Product Code
- LJP FDA UDI
- EMDN Code
- W0105010107 CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION EUDAMED
- GMDN Term
- Multiple Chlamydia species antigen IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3120 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Imagen Chlamydia Kit by Oxoid Ltd — Class C — 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 | 5032384ImagenChlamydiaW7 | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | 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 9d3f2889-72a2-400c-b26c-4cefd29e5e40 61 fields · synced Jun 19, 2026
- FDA UDI 966b90f2-4af9-4845-a007-70079e61a2f5 32 fields · synced May 30, 2026