Identity
- Trade Name
- DIFCO EUDAMEDBD Difco™ Salmonella H Antiserum Spicer-Edwards 1 FDA UDI
- Generic Name
- Multiple Salmonella species antigen IVD, reagent FDA UDI
- Device Name
- BD Difco™ Salmonella O Antiserum Family EUDAMEDBD Difco™ Salmonella H Antiserum Spicer-Edwards 1, 3 mL FDA UDI
- Model / Reference
- 222651 EUDAMEDFDA UDI
- Description
- BD Difco™ Salmonella H Antiserum Spicer-Edwards 1, 3 mL FDA UDI
Identifiers
- Catalog Number
- 222651 FDA UDI
- Primary DI / UDI-DI
- 00382902226512 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290HHBTINSQ7Q EUDAMED
- FDA Product Code
- GRM FDA UDI
- EMDN Code
- W0104080301 SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC) EUDAMED
- GMDN Term
- Multiple Salmonella species antigen IVD, reagent 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
Yes
Microbial Substances
Yes
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 — 3 Milliliter FDA UDI
Becton, Dickinson and Company's DIFCO medical device is a high-quality antiserum family for the prevention of Salmonella infections. With its robust regulatory compliance and standard testing criteria, it's an ideal solution for various medical applications.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290HHBTINSQ7Q | 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 34eb54ca-ca92-4fe5-87aa-55702cb44095 61 fields · synced Jul 11, 2026
- FDA UDI abbdfb8d-2f3e-4817-9b1f-7dc2cec3bab3 37 fields · synced May 29, 2026