Duns Number:276816717
Device Description: Chromogenic medium for the screening and qualitative detection of methicillin-resistant St Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus and selective isolation of staphylococci and the direct identification of S. aureus.
Catalog Number
-
Brand Name
chromID™ MRSA /SAID
Version/Model Number
chromID™ MRSA /SAID
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
K151688,K162076,K151688,K162076,K151688,K162076
Product Code
JSO
Product Code Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Public Device Record Key
06e8cd8d-c755-48ed-9b57-b1fb33121444
Public Version Date
February 06, 2020
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
03573026420758
Quantity per Package
2
Contains DI Package
03573026552091
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 |