Identity
- Trade Name
- PRAS BBE EUDAMEDPRAS Bacteroides Bile Esculin Agar (BBE) FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-114 Bacteroides Bile Esculin (BBE) agar is an enriched, selective, and differential medium used for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila wadsworthia. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent yellow/green color. 1 plate per pack. FDA UDI
- Model / Reference
- AS-114 EUDAMEDFDA UDI
- Description
- AS-114 Bacteroides Bile Esculin (BBE) agar is an enriched, selective, and differential medium used for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila wadsworthia. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent yellow/green color. 1 plate per pack. FDA UDI
Identifiers
- Catalog Number
- AS-114 FDA UDI
- Primary DI / UDI-DI
- 00810048900046 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- FDA Product Code
- JSI FDA UDI
- EMDN Code
- W0104010405 NON-CHROMOGENIC MEDIA (PLATES) EUDAMED
- GMDN Term
- Differential/selective agar culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Pras Bbe by Anaerobe Systems — Class A — 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 | 081004890ANAEROBEDT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Anaerobe Systems
- EUDAMED SRN
- US-MF-000040030
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (2)
- EUDAMED 951b1c58-1479-41bf-be71-74ef2473092f 61 fields · synced Jun 19, 2026
- FDA UDI 708e6370-1c05-4e88-babd-999af8f26d11 36 fields · synced May 30, 2026