Identity
- Trade Name
- DIFCO EUDAMEDBD Difco™ Bordetella Parapertussis Antiserum FDA UDI
- Generic Name
- Multiple Bordetella species antigen IVD, reagent FDA UDI
- Device Name
- BD Difco™ Bordetella Pertussis Antiserum and BD Difco™ Bordetella Parapertussis Antiserum EUDAMEDBD Difco™ Bordetella Parapertussis Antiserum FDA UDI
- Model / Reference
- 223101 EUDAMEDFDA UDI
- Description
- BD Difco™ Bordetella Parapertussis Antiserum FDA UDI
Identifiers
- Catalog Number
- 223101 FDA UDI
- Primary DI / UDI-DI
- 00382902231011 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290YBFHBQIQA5 EUDAMED
- FDA Product Code
- GOW FDA UDI
- EMDN Code
- W0104080301 SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC) EUDAMED
- GMDN Term
- Multiple Bordetella species antigen IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3065 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Difco by Becton Dickinson And Company — 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 | 038290YBFHBQIQA5 | 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 0a2c1b31-f4e7-487d-b3d5-2eccd01633af 61 fields · synced Jun 18, 2026
- FDA UDI cba4e3f8-2fc8-431b-9d8b-bc2d009f0ade 37 fields · synced May 30, 2026