Duns Number:039981550
Device Description: HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromogenic medium HardyCHROM™ Sakazakii, 15x100mm Plate, 18ml. HardyCHROM™ Sakazakii is a chromogenic medium recommended for the selective isolation and differentiation of Cronobacter (Enterobacter) sakazakii from other members of the family Enterobacteriaceae based on colony color.
Catalog Number
G315
Brand Name
HardyCHROM
Version/Model Number
G315
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2022
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
JSH
Product Code Name
Culture Media, Non-Selective And Differential
Public Device Record Key
854d4173-b76e-4928-8a6a-491c9e3ecbe4
Public Version Date
March 01, 2022
Public Version Number
2
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 |