Identity
- Trade Name
- PRAS BRU, BBE/PEA (2 plates /pkg) EUDAMEDPRAS BRU BBE/PEA Convenience Pack FDA UDI
- Generic Name
- Multiple formulation agar culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-322 BRU and BBE/PEA Convenience Pack - Includes 1 Brucella Blood Agar (BRU) and 1 Bacteroides Bile Esculin Agar (BBE)/Phenylethyl Alcohol Blood Agar (PEA) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. BBE is transparent yellow/green. PEA is opaque red. 2 plates per pack. FDA UDI
- Model / Reference
- AS-322 EUDAMEDFDA UDI
- Description
- AS-322 BRU and BBE/PEA Convenience Pack - Includes 1 Brucella Blood Agar (BRU) and 1 Bacteroides Bile Esculin Agar (BBE)/Phenylethyl Alcohol Blood Agar (PEA) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. BBE is transparent yellow/green. PEA is opaque red. 2 plates per pack. FDA UDI
Identifiers
- Catalog Number
- AS-322 FDA UDI
- Primary DI / UDI-DI
- 00810048901319 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- FDA Product Code
- KZI FDA UDIJSH FDA UDIJSJ FDA UDIJSI FDA UDI
- EMDN Code
- W0104010405 NON-CHROMOGENIC MEDIA (PLATES) EUDAMED
- GMDN Term
- Multiple formulation agar culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2330 FDA UDI866.2320 FDA UDI866.2360 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
Yes
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 BRU, BBE/PEA (2 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 cd1ed39a-812f-4232-bd24-9421d3061caa 61 fields · synced Jun 18, 2026
- FDA UDI c7daa8e1-0830-4b02-b87a-d6948cc54b58 36 fields · synced May 30, 2026