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Reagent Spot Indole Dmaca
EUDAMEDFDA UDIClass A (EU MDR)
Ref MB1448A
by Oxoid Ltd
Identity
- Trade Name
- REAGENT SPOT INDOLE DMACA EUDAMEDFDA UDI
- Generic Name
- Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
- Device Name
- REAGENT SPOT INDOLE DMACA EUDAMED
- Model / Reference
- MB1448A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384127993 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384ReagSpotIndoleYH EUDAMED
- FDA Product Code
- LIB FDA UDI
- EMDN Code
- W0104080201 GRAM NEGATIVE - MANUAL IDENTIFICATION EUDAMED
- GMDN Term
- Multiple bacteria species culture isolate identification control IVD, kit FDA UDI
Classification
- Device Class
- Class A 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Reagent Spot Indole Dmaca by Oxoid Ltd — Class A — 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 | 5032384ReagSpotIndoleYH | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 f3e85bef-7016-4da0-bcc5-e0ccd02d68f8 61 fields · synced Jun 18, 2026
- FDA UDI 57161355-3e9e-45a4-95f9-75c05a5cd50f 32 fields · synced May 29, 2026