Identity
- Trade Name
- HardyFlask™ FDA UDI
- Generic Name
- Basic/simple nutrient agar culture medium IVD FDA UDI
- Device Name
- Sabdex (Sabouraud Dextrose) Agar, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts. FDA UDI
- Model / Reference
- X40 FDA UDI
- Description
- Sabdex (Sabouraud Dextrose) Agar, 12ml, 50ml plastic HardyFlask™, order by the package of 20 Recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts. FDA UDI
Identifiers
- Catalog Number
- X40 FDA UDI
- Primary DI / UDI-DI
- 00819398024341 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic/simple nutrient agar culture medium IVD
HardyFlask™ by Hardy Diagnostics — 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
- BD BBL™ Trypticase™ Soy Agar (Soybean-Casein Digest Agar) — BECTON DICKINSON AND COMPANY · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- OxyPRAS Plus Brucella Agar plate — Oxyrase, Inc. · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · 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
- Hardy Diagnostics
Sources (1)
- FDA UDI 2a52fd87-99b1-44b3-b5f8-23912c0cbf52 36 fields · synced Jun 6, 2026