Duns Number:039981550
Device Description: Lysostaphin, differentiates between Micrococcus and Staphylococcus, HardyDisk™, 50 disks p Lysostaphin, differentiates between Micrococcus and Staphylococcus, HardyDisk™, 50 disks per cartridgeUsed to rapidly differentiate Staphylococcus spp. and Micrococcus spp. based on lysostaphin resistance. Make a suspension of the bacteria, add the disk, look for a clearing of turbidity if Staph is present.
Catalog Number
Z112
Brand Name
N/A
Version/Model Number
Z112
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
-
Product Code
JTO
Product Code Name
Discs, Strips And Reagents, Microorganism Differentiation
Public Device Record Key
8fac6b6b-59d8-4d4b-8aae-3d93511ce576
Public Version Date
July 17, 2020
Public Version Number
1
DI Record Publish Date
July 09, 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 |