Identity
- Trade Name
- Schaedler Blood Agar OxyPlate FDA UDI
- Generic Name
- Enriched agar culture medium IVD FDA UDI
- Device Name
- Culture Media, Enriched FDA UDI
- Model / Reference
- O-SW-BA FDA UDI
- Description
- Culture Media, Enriched FDA UDI
Identifiers
- Catalog Number
- O-SW-BA FDA UDI
- Primary DI / UDI-DI
- 00850056467063 FDA UDI
- FDA Product Code
- KZI FDA UDI
- GMDN Term
- Enriched agar culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2330 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: Enriched agar culture medium IVD
Schaedler Blood Agar OxyPlate by Oxyrase, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enriched agar culture medium IVD.
- AnaeroGRO — HARDY DIAGNOSTICS · Class I
- BD BBL™ Trypticase™ Soy Agar Modified (TSA II) Deeps — BECTON DICKINSON AND COMPANY · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- AnaeroGRO — HARDY DIAGNOSTICS · Class I
- REMEL — REMEL, INC. · Class I
- BD BBL™ Brucella Agar with 5% Sheep Blood, Hemin and Vitamin K1 — BECTON DICKINSON AND COMPANY · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- AnaeroGRO — HARDY DIAGNOSTICS · 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 f8277efd-875b-49b6-b27e-fb358afe199f 37 fields · synced Jun 8, 2026