Duns Number:039981550
Device Description: HardyCHROM™ CRE, 15x100mm Plate, 18mlHardyCHROM™ CRE is a selective and differential chrom HardyCHROM™ CRE, 15x100mm Plate, 18mlHardyCHROM™ CRE is a selective and differential chromogenic agar medium intended for the qualitative and presumptive detection from stool specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES (Klebsiella aerogenes, Klebsiella oxytoca,Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens) that are non-susceptible to carbapenems as blue colonies.
Catalog Number
G323
Brand Name
HardyCHROM™
Version/Model Number
G323
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
K190553,K190553
Product Code
JSO
Product Code Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Public Device Record Key
c78d3510-f1a5-45c0-9c3c-e9e8f5ba3137
Public Version Date
October 29, 2019
Public Version Number
1
DI Record Publish Date
October 21, 2019
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 |