Identity
- Trade Name
- PRAS BSM (4 plates /pkg) EUDAMEDPRAS Botulism Selective Medium (BSM) FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-223 Botulism Selective Medium (BSM) is a selective and differential medium for the presumptive identification of Clostridium botulinum from food or clinical samples. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque light yellow. 4 plates per pack. FDA UDI
- Model / Reference
- AS-223 EUDAMEDFDA UDI
- Description
- AS-223 Botulism Selective Medium (BSM) is a selective and differential medium for the presumptive identification of Clostridium botulinum from food or clinical samples. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque light yellow. 4 plates per pack. FDA UDI
Identifiers
- Catalog Number
- AS-223 FDA UDI
- Primary DI / UDI-DI
- 00810048900176 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 BSM (4 plates /pkg) 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 4153e3e6-8229-4142-af7d-8e0848909e98 61 fields · synced Jun 19, 2026
- FDA UDI fd5d5a19-421e-4c81-9383-1f16bb6d9ebd 36 fields · synced May 30, 2026