Identity
- Trade Name
- DIFCO EUDAMEDBD Difco™ Escherichia coli O Antiserum O157 FDA UDI
- Generic Name
- Escherichia coli antigen IVD, kit, agglutination FDA UDI
- Device Name
- BD Difco™ E. Coli O Antiserum O157 EUDAMEDDifco™ E. Coli O Antiserum O157 FDA UDI
- Model / Reference
- 229701 EUDAMEDFDA UDI
- Description
- Difco™ E. Coli O Antiserum O157 FDA UDI
Identifiers
- Catalog Number
- 229701 FDA UDI
- Primary DI / UDI-DI
- 00382902297017 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290OJQEIVFDD4 EUDAMED
- FDA Product Code
- GNA FDA UDI
- EMDN Code
- W0104080301 SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC) EUDAMED
- GMDN Term
- Escherichia coli antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3255 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
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
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 — 3 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 | 038290OJQEIVFDD4 | 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 367c6cc2-8be3-459e-be89-e2db30a0d2a6 61 fields · synced Jun 19, 2026
- FDA UDI 23526fb1-52fb-4fa3-867f-7a765d8feb78 37 fields · synced May 30, 2026