Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
- Device Name
- HardyDisks™ AST, Meropenem/Vaborbactam, Vabomere, for susceptibility testing, 5 x 50 disks, by Hardy Diagnostics HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. FDA UDI
- Model / Reference
- Z9325 FDA UDI
- Description
- HardyDisks™ AST, Meropenem/Vaborbactam, Vabomere, for susceptibility testing, 5 x 50 disks, by Hardy Diagnostics HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae. FDA UDI
Identifiers
- Catalog Number
- Z9325 FDA UDI
- Primary DI / UDI-DI
- 00816576023509 FDA UDI
- 510(k) Number
- K172621 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent 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: Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
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
K172621 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 42252aff-905e-42d1-8cf0-e68e43cd7d31 37 fields · synced Jun 8, 2026