Identity
- Trade Name
- PRAS CA (4 plates /pkg) EUDAMEDPRAS Columbia Blood Agar (CA) FDA UDI
- Generic Name
- Enriched agar culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-895 Columbia Blood Agar (CA) is intended for the isolation, quantitation, and partial identification of a variety of microorganisms, including fastidious organisms from clinical specimens. CA is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack. FDA UDI
- Model / Reference
- AS-895 EUDAMEDFDA UDI
- Description
- AS-895 Columbia Blood Agar (CA) is intended for the isolation, quantitation, and partial identification of a variety of microorganisms, including fastidious organisms from clinical specimens. CA is suitable for use in antibiotic differential disk examination and spot biochemical testing. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Opaque red. 4 plates per pack. FDA UDI
Identifiers
- Catalog Number
- AS-895 FDA UDI
- Primary DI / UDI-DI
- 00810048901166 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- FDA Product Code
- JSH FDA UDIKZI FDA UDI
- EMDN Code
- W0104010405 NON-CHROMOGENIC MEDIA (PLATES) EUDAMED
- GMDN Term
- Enriched agar culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2320 FDA UDI866.2330 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
No
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Our PRAS CA (4 plates /pkg) device is a reliable and efficient anaerobic culture medium, designed for the development of effective microbiological cultures in various clinical and research settings. With its robust sterilization process and accurate measuring function, this device ensures high-quality results in patient care.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
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 329c8a06-4e95-4255-b3c4-3f1eb641a37f 61 fields · synced Jul 25, 2026
- FDA UDI 26abf99f-60ba-4a2e-a657-67502a128ccc 36 fields · synced May 29, 2026