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Staphaurex Latex Agglutination Test (400 Tests)
EUDAMEDFDA UDIClass B (EU MDR)
Ref R30859902
Identity
- Trade Name
- Staphaurex Latex Agglutination Test (400 Tests) EUDAMEDStaphaurex (400 test) FDA UDI
- Generic Name
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- STAPHAUREX LATEX AGGLUTATION TEST EUDAMED
- Model / Reference
- R30859902 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501505 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560805StapharexLD EUDAMED
- 510(k) Number
- K851949 FDA UDI
- FDA Product Code
- GTN FDA UDI
- EMDN Code
- W0104080303 STAPHYLOCOCCI SLIDE TESTS EUDAMED
- GMDN Term
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3700 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
Staphaurex Latex Agglutination Test (400 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 | 50560805StapharexLD | 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 be88cf12-d114-4b81-9b78-2c298b43a453 61 fields · synced Jul 8, 2026
- FDA UDI b7bb0fe7-af8f-47ac-b4f5-643213026263 34 fields · synced May 30, 2026