Duns Number:605213545
Device Description: Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumeration of stap Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumeration of staphylococci from clinical/non-clinical materials. A change of the phenol red indicator (Mannitol fermentation) aids in differentiating staphylococci species.
Catalog Number
21-303-001
Brand Name
InTray® MSA
Version/Model Number
1303
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
5d1f6013-4244-4346-83c4-63ad364e1e7e
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 12, 2018
Package DI Number
B08813034
Quantity per Package
20
Contains DI Package
B08813030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box