Identity
- Trade Name
- DIFCO EUDAMEDBD Difco™ QC Antigen Salmonella O Group A FDA UDI
- Generic Name
- Multiple Salmonella species antigen IVD, control FDA UDI
- Device Name
- BD Difco™ QC Antigen Salmonella O Group A, BD Difco™ QC Antigen Salmonella O Group D and BD Difco™ QC Antigen Salmonella Vi EUDAMEDBD Difco™ QC Antigen Salmonella O Group A, 1 mL FDA UDI
- Model / Reference
- 221301 EUDAMEDFDA UDI
- Description
- BD Difco™ QC Antigen Salmonella O Group A, 1 mL FDA UDI
Identifiers
- Catalog Number
- 221301 FDA UDI
- Primary DI / UDI-DI
- 00382902213017 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290KYXKQAGXPE EUDAMED
- FDA Product Code
- GRL FDA UDI
- EMDN Code
- W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED
- GMDN Term
- Multiple Salmonella species antigen IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3550 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
Yes
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Multiple bacteria species culture isolate identification control IVD, kit
Difco by Becton Dickinson And Company — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290KYXKQAGXPE | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (2)
- EUDAMED 1d2443ab-ba09-44a6-95ca-192af8863cd4 61 fields · synced Jun 18, 2026
- FDA UDI d0d9e186-ad3e-481d-91fc-513c052793ef 37 fields · synced May 29, 2026