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B Bacitracin For Differentiation
EUDAMEDFDA UDIClass B (EU MDR)
Ref DD0030S
by Oxoid Ltd
Identity
- Trade Name
- B BACITRACIN FOR DIFFERENTIATION EUDAMEDOxoid™ Bacitracin Diagnostic Discs FDA UDI
- Generic Name
- Bacitracin differentiation disc IVD FDA UDI
- Device Name
- BACITRACIN EUDAMED
- Model / Reference
- DD0030S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384188796 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384BacitracinDDR5 EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W0104080208 SINGLE TESTS (DISCS, STRIPS, DROPPERS...) EUDAMED
- GMDN Term
- Bacitracin differentiation disc IVD FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
B Bacitracin For Differentiation 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 | 5032384BacitracinDDR5 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED b604f022-5b23-43a6-9475-5f86dea9894d 61 fields · synced Jun 18, 2026
- FDA UDI 98132d21-3379-4ade-860c-6cca49e6c151 33 fields · synced May 30, 2026