Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Chloramphenicol susceptibility testing disc IVD FDA UDI
- Device Name
- Chloramphenicol 30μg (C30) 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
- Z8345 FDA UDI
- Description
- Chloramphenicol 30μg (C30) 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
- Z8345 FDA UDI
- Primary DI / UDI-DI
- 00816576020577 FDA UDI
- 510(k) Number
- K994089 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Chloramphenicol susceptibility testing disc 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: Chloramphenicol susceptibility testing disc IVD
HardyDisk™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chloramphenicol susceptibility testing disc IVD.
- HardyDisk™ — HARDY DIAGNOSTICS · Class II
Cleared under the same submission
K994089 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 33241798-5563-4849-ba23-28a98038c756 37 fields · synced Jun 8, 2026