Identity
- Trade Name
- OxyPRAS Plus Bile Esculin plate FDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- Culture Media, Selective and Non-Differential FDA UDI
- Model / Reference
- P-BBE-NB FDA UDI
- Description
- Culture Media, Selective and Non-Differential FDA UDI
Identifiers
- Catalog Number
- P-BBE-NB FDA UDI
- Primary DI / UDI-DI
- 00850056467056 FDA UDI
- FDA Product Code
- JSJ FDA UDI
- GMDN Term
- Differential/selective agar culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 24 Gram FDA UDI
Category: Differential/selective agar culture medium IVD
OxyPRAS Plus Bile Esculin plate by Oxyrase, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Oxyrase, Inc.
Sources (1)
- FDA UDI ac16ad1d-fd2e-4fa0-bf01-ab572362986a 37 fields · synced Jun 8, 2026