Duns Number:039981550
Device Description: Columbia CNA Agar with Esculin / Hektoen Enteric (HE) Agar, 15x100mm Biplate, 10ml/10ml. H Columbia CNA Agar with Esculin / Hektoen Enteric (HE) Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Columbia CNA Agar is recommended for use as a selective growth medium for the isolation and differentiation of gram-positive cocci from clinical and non-clinical specimens which contain mixed flora. Hardy Diagnostics Hektoen Enteric (HE) Agar is a selective and differential medium used for the isolation and differentiation of gram-negative enteric pathogens.
Catalog Number
J67
Brand Name
N/A
Version/Model Number
J67
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
38124d09-57bf-418b-83c9-562e5bb1d6db
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 24, 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 |