Identity
- Trade Name
- HardyFlask™ FDA UDI
- Generic Name
- Enriched agar culture medium IVD FDA UDI
- Device Name
- Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species. FDA UDI
- Model / Reference
- X26 FDA UDI
- Description
- Middlebrook 7H10 Agar, 12ml fill, 50ml plastic HardyFlask™, order by the package of 20 Middlebrook 7H10 Agar is recommended for use in qualitative procedures for the isolation and cultivation of Mycobacterium species. FDA UDI
Identifiers
- Catalog Number
- X26 FDA UDI
- Primary DI / UDI-DI
- 00819398024242 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
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: Enriched agar culture medium IVD
HardyFlask™ by Hardy Diagnostics — 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
- Hardy Diagnostics
Sources (1)
- FDA UDI 32d34551-3973-49ca-85a8-7e23c22a449f 36 fields · synced May 31, 2026