Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
- Device Name
- HardyDisk™ AST Lefamulin, 20µg (LMU20), 1 x 50 disks 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
- Z9451 FDA UDI
- Description
- HardyDisk™ AST Lefamulin, 20µg (LMU20), 1 x 50 disks 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
- Z9451 FDA UDI
- Primary DI / UDI-DI
- 00819398028189 FDA UDI
- 510(k) Number
- K192326 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
Similar devices
Also classified as Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent.
- BD Phoenix™ NMIC/ID-302 — BECTON DICKINSON AND COMPANY · Class II
- BD Phoenix™ SMIC-101 — BECTON DICKINSON AND COMPANY · Class II
- NMIC-312 — BECTON DICKINSON AND COMPANY · Class II
- BD Phoenix™ NID — BECTON DICKINSON AND COMPANY · Class I
- REMEL — REMEL, INC. · Class I
- NMIC/ID-313 — BECTON DICKINSON AND COMPANY · Class II
- BD Phoenix™ NMIC-311 — BECTON DICKINSON AND COMPANY · Class II
- BD Phoenix™ NMIC/ID-307 — BECTON DICKINSON AND COMPANY · Class II
Cleared under the same submission
K192326 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 9db608c3-778b-4a02-b0c8-dbde1db3236d 37 fields · synced May 30, 2026