Duns Number:276816717
Device Description: Chromogenic medium for the qualitative detection of Enterococcus faecium and E. faecalis s Chromogenic medium for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens.
Catalog Number
-
Brand Name
CHROMID® VRE Agar
Version/Model Number
chromID™ VRE Agar
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
K091025,K091025,K091025
Product Code
JSO
Product Code Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Public Device Record Key
f76c562d-1705-47cd-ade2-af147f894656
Public Version Date
January 14, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
03573026313128
Quantity per Package
2
Contains DI Package
03573026552138
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |