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Wellcolex Colour Shigella (50 tests)
EUDAMEDFDA UDIClass B (EU MDR)
Ref R30858401
Identity
- Trade Name
- Wellcolex Colour Shigella (50 tests) EUDAMEDNA FDA UDI
- Generic Name
- Multiple Shigella species culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- WELLCOLEX COLOUR SHIGELLA EUDAMED
- Model / Reference
- R30858401 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080500492 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560805WCShigellaNK EUDAMED
- 510(k) Number
- K895461 FDA UDI
- FDA Product Code
- GNB FDA UDI
- EMDN Code
- W0104080301 SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC) EUDAMED
- GMDN Term
- Multiple Shigella species culture isolate antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3660 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 Shigella (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 | 50560805WCShigellaNK | 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 e2b3336d-005b-428d-a148-3c39c39708d1 61 fields · synced Jul 9, 2026
- FDA UDI c0fabfec-2202-4068-8768-ea3df69cd1e3 34 fields · synced May 30, 2026