Duns Number:069550929
Device Description: (Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion m (Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method.
Catalog Number
NCM0023E
Brand Name
Mueller Hinton Agar II
Version/Model Number
0
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K811049
Product Code
JTZ
Product Code Name
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Public Device Record Key
ddab67c2-f9a2-4489-bb3d-631900d8a81f
Public Version Date
October 28, 2020
Public Version Number
1
DI Record Publish Date
October 20, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |