Duns Number:039981550
Device Description: HardyCHROM™ Salmonella / XLT-4 Agar, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ Salmonella i HardyCHROM™ Salmonella / XLT-4 Agar, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ Salmonella is a chromogenic medium recommended for the selective isolation and differentiation of Salmonella spp. from other members of the family Enterobacteriaceae based on colony color. Hardy Diagnostics XLT-4 Agar is a highly selective plating medium for the detection and isolation of non-typhi Salmonella species.
Catalog Number
J37
Brand Name
HardyCHROM
Version/Model Number
J37
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
a753e2de-407c-4783-97e7-c91218d83ba6
Public Version Date
May 29, 2020
Public Version Number
1
DI Record Publish Date
May 21, 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 |