Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Antibacterial susceptibility testing disc IVD FDA UDI
- Device Name
- Blank disks, 0.25 inch diameter paper disk for AST, 1 x 50 disks A blank paper disk that can be used for inhibition studies. Used to prepare your own disks for Kirby Bauer (antimicrobial disk diffusion (AST)) testing on Mueller Hinton Agar. FDA UDI
- Model / Reference
- Z7121 FDA UDI
- Description
- Blank disks, 0.25 inch diameter paper disk for AST, 1 x 50 disks A blank paper disk that can be used for inhibition studies. Used to prepare your own disks for Kirby Bauer (antimicrobial disk diffusion (AST)) testing on Mueller Hinton Agar. FDA UDI
Identifiers
- Catalog Number
- Z7121 FDA UDI
- Primary DI / UDI-DI
- 00816576028436 FDA UDI
- FDA Product Code
- JTO FDA UDI
- GMDN Term
- Antibacterial susceptibility testing disc IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antibacterial susceptibility testing disc IVD
HardyDisk™ 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 816e566c-f510-4cd8-bf45-d12d728463cd 36 fields · synced Jun 8, 2026