Duns Number:039981550
Device Description: Bacitracin 0.04 units, HardyDisks™, for the differentiation of Group A Strep (Streptococcu Bacitracin 0.04 units, HardyDisks™, for the differentiation of Group A Strep (Streptococcus pyogenes), 50 disks per cartridge, 5 cart., not for antimicrobial sensitivity tests,Used in the presumptive identification of group A, beta-hemolytic streptococci. The test differentiates group A streptococci from other Lancefield groups of hemolytic streptococci by inhibiting the growth of group A streptococci around a disk containing approximately 0.04 units bacitracin.
Catalog Number
Z7025
Brand Name
HardyDisk™
Version/Model Number
Z7025
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K011086,K011086
Product Code
JTN
Product Code Name
Susceptibility Test Discs, Antimicrobial
Public Device Record Key
38e44df0-6ea6-4d9a-b907-25b0194e2253
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 2020
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 |