Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Antimicrobial sensitivity disc dispenser IVD FDA UDI
- Device Name
- HardyDisk™ AST Gepotidacin, 10ug (GEP10), 5 x 50 disks For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin. FDA UDI
- Model / Reference
- Z9495 FDA UDI
- Description
- HardyDisk™ AST Gepotidacin, 10ug (GEP10), 5 x 50 disks For in vitro agar diffusion susceptibility testing when there is the need to determine the susceptibility of Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis to gepotidacin. FDA UDI
Identifiers
- Catalog Number
- Z9495 FDA UDI
- Primary DI / UDI-DI
- 00816576027194 FDA UDI
- 510(k) Number
- K250956 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Antimicrobial sensitivity disc dispenser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1620 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
Yes
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: Antimicrobial sensitivity disc dispenser IVD
HardyDisk™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K250956 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 1222ac4e-1448-48bd-9323-5fe1845fddf9 37 fields · synced May 30, 2026