← Back to catalogue
Pbp2 Latex Agglutination Test Kit
EUDAMEDFDA UDIClass B (EU MDR)
Ref DR0900A
by Oxoid Ltd
Identity
- Trade Name
- PBP2 LATEX AGGLUTINATION TEST KIT EUDAMEDNA FDA UDI
- Generic Name
- Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- PBP2 LATEX AGGLUTINATION TEST KIT EUDAMED
- Model / Reference
- DR0900A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384096442 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384PBP2LatexKitEW EUDAMED
- 510(k) Number
- K011710 FDA UDI
- FDA Product Code
- MYI 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 II FDA UDI
- Regulation Number
- 866.1640 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
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
Pbp2 Latex Agglutination Test Kit by Oxoid 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 | 5032384PBP2LatexKitEW | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | 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 a5cb3a8b-055a-412b-9cec-c535d2bf8fe8 61 fields · synced Jul 26, 2026
- FDA UDI b4e9218a-9f0a-4847-a74b-604af5d7c246 34 fields · synced May 29, 2026