Identity
- Trade Name
- OxyPRAS Plus Brucella Agar plate FDA UDI
- Generic Name
- Basic/simple nutrient agar culture medium IVD FDA UDI
- Device Name
- Cultured Media, Non-Selective and Non-Differential FDA UDI
- Model / Reference
- P-BRU-BA FDA UDI
- Description
- Cultured Media, Non-Selective and Non-Differential FDA UDI
Identifiers
- Catalog Number
- P-BRU-BA FDA UDI
- Primary DI / UDI-DI
- 00850056467001 FDA UDI
- FDA Product Code
- JSG FDA UDI
- GMDN Term
- Basic/simple nutrient agar culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2300 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: Basic/simple nutrient agar culture medium IVD
OxyPRAS Plus Brucella Agar plate by Oxyrase, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic/simple nutrient agar culture medium IVD.
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- HardyFlask™ — HARDY DIAGNOSTICS · Class I
- BD BBL™ Trypticase™ Soy Agar (Soybean-Casein Digest Agar) — BECTON DICKINSON AND COMPANY · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- HardyFlask™ — HARDY DIAGNOSTICS · Class I
- HardyFlask™ — HARDY DIAGNOSTICS · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oxyrase, Inc.
Sources (1)
- FDA UDI b7c91536-773b-45be-8eb6-e7e6fa0d720c 37 fields · synced Jun 8, 2026