Duns Number:039981550
Device Description: HardyCHROM™ ESBLA chromogenic medium for use as a primary screening method for the detecti HardyCHROM™ ESBLA chromogenic medium for use as a primary screening method for the detection and differentiation of Extended-Spectrum Beta-Lactamase producing Enterobacteriaciae. Some ingredients are very light sensitive. Store and incubate in the dark.
Catalog Number
G321
Brand Name
HardyCHROM™
Version/Model Number
G321
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160512,K160512
Product Code
JSO
Product Code Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Public Device Record Key
d785fecf-87f5-43a8-a788-f6277347508b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 28, 2017
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 |