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Wellcolex Colour Salmonella (50 tests)
EUDAMEDFDA UDIClass B (EU MDR)
Ref R30858301
Identity
- Trade Name
- Wellcolex Colour Salmonella (50 tests) EUDAMEDNA FDA UDI
- Generic Name
- Multiple Salmonella species culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- WELLCOLEX COLOUR SALMONELLA EUDAMED
- Model / Reference
- R30858301 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080500485 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560805WCSalmonellaNB EUDAMED
- 510(k) Number
- K890146 FDA UDI
- FDA Product Code
- GRM FDA UDI
- EMDN Code
- W0104080301 SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC) EUDAMED
- GMDN Term
- Multiple Salmonella species culture isolate antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3550 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Wellcolex Colour Salmonella (50 tests) by Remel Europe 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 | 50560805WCSalmonellaNB | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Remel Europe Ltd
- EUDAMED SRN
- GB-MF-000016733
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED ef4e1c55-bacd-4db8-9c8c-4a518cdf4030 61 fields · synced Jul 20, 2026
- FDA UDI c1285dae-25ea-43cd-8ad6-3f3fd07f65b2 34 fields · synced May 29, 2026