Duns Number:039981550
Device Description: HUrBi™, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ HUrBi™ Biplate is a selective chromogenic HUrBi™, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ HUrBi™ Biplate is a selective chromogenic medium recommended for the cultivation, differentiation and enumeration of various gram-negative and gram-positive bacteria, and yeast based on colony color and morphology. Selective agents have been added to the each side of the biplate to select for growth of gram-positive organisms and yeast on one side and to select for growth of gram-negative organisms on the other side of the biplate.
Catalog Number
J100
Brand Name
HardyCHROM
Version/Model Number
J100
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
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
83f8362b-460b-4ffd-8513-62af60a86414
Public Version Date
May 28, 2020
Public Version Number
1
DI Record Publish Date
May 20, 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 |