Identity
- Trade Name
- PRAS TSBV (4 plates /pkg) EUDAMEDPRAS Tryptic Soy Serum Bacitracin Vancomycin Agar (TSBV) FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-648 Tryptic Soy Serum Bacitracin Vancomycin Agar (TSBV) is an enriched selective medium used for the isolation and presumptive identification of Aggregatibacter actinomycetemcomitans from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow. 4 plates per pack. FDA UDI
- Model / Reference
- AS-648 EUDAMEDFDA UDI
- Description
- AS-648 Tryptic Soy Serum Bacitracin Vancomycin Agar (TSBV) is an enriched selective medium used for the isolation and presumptive identification of Aggregatibacter actinomycetemcomitans from clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent light yellow. 4 plates per pack. FDA UDI
Identifiers
- Catalog Number
- AS-648 FDA UDI
- Primary DI / UDI-DI
- 00810048900459 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 TSBV (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 f075a06b-5d08-4b50-b757-f32f80c58aa8 61 fields · synced Jul 17, 2026
- FDA UDI f792877b-9d98-428b-bd0d-618e56f0930c 36 fields · synced May 30, 2026