Identity
- Trade Name
- PRAS FSA (4 plates /pkg) EUDAMEDPRAS Fusobacterium Selective Agar (FSA) FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-6427 Fusobacterium Selective Agar (FSA) is an enriched selective medium for the isolation and presumptive identification of Fusobacterium species. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack. FDA UDI
- Model / Reference
- AS-6427 EUDAMEDFDA UDI
- Description
- AS-6427 Fusobacterium Selective Agar (FSA) is an enriched selective medium for the isolation and presumptive identification of Fusobacterium species. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack. FDA UDI
Identifiers
- Catalog Number
- AS-6427 FDA UDI
- Primary DI / UDI-DI
- 00810048900381 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- FDA Product Code
- JSJ 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 FSA (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 425d79f6-f864-4bc4-a24d-2641714fe2c9 61 fields · synced Jun 18, 2026
- FDA UDI 6131f021-4faf-401c-a8a6-535fa539e4de 36 fields · synced May 30, 2026