Duns Number:039981550
Device Description: HardyDisks™ AST, Delafloxacin, Baxdela, for susceptibility testing, 5 x 50 disks, by Hardy HardyDisks™ AST, Delafloxacin, Baxdela, for susceptibility testing, 5 x 50 disks, by Hardy DiagnosticsHardyDisk™ 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.
Catalog Number
Z9305
Brand Name
HardyDisk™
Version/Model Number
Z9305
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171975,K171975
Product Code
JTN
Product Code Name
Susceptibility Test Discs, Antimicrobial
Public Device Record Key
e749e426-5fa3-45f6-8ff1-a803a58f9e3a
Public Version Date
January 07, 2019
Public Version Number
1
DI Record Publish Date
December 07, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |