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BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1-4
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1-4 FDA UDI
- Generic Name
- Escherichia coli antigen IVD, antibody FDA UDI
- Device Name
- BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1–4 FDA UDI
- Model / Reference
- 228381 FDA UDI
- Description
- BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1–4 FDA UDI
Identifiers
- Catalog Number
- 228381 FDA UDI
- Primary DI / UDI-DI
- 00382902283812 FDA UDI
- FDA Product Code
- GNB FDA UDI
- GMDN Term
- Escherichia coli antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
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
Category: Escherichia coli antigen IVD, antibody
BD Difco™ Alkalescens-Dispar Antiserum Poly Contains Types 1-4 by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Escherichia coli antigen IVD, antibody.
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- E. coli H15 serum, 5 mL — Ssi Diagnostica A/S · Class I
- E. coli H43 serum, 5 mL — Ssi Diagnostica A/S · Class I
- E. coli O181 serum, 1 mL — Ssi Diagnostica A/S · Class I
- E. coli O81 serum, 1 mL — Ssi Diagnostica A/S · Class I
- E. coli O100 serum, 1 mL — Ssi Diagnostica A/S · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI c522dd9c-5631-468d-827a-0b1486d9e708 36 fields · synced May 30, 2026