Duns Number:605213545
Device Description: A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, inclu A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approximately 5.6) is favorable for growth of fungi, especially yeasts and dermatophytes. Sabouraud's Dextrose Agar (SAB) is slightly inhibitory to contaminating bacteria in clinical specimens.
Catalog Number
21-263-001
Brand Name
InTray® SAB
Version/Model Number
1263
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
JSG
Product Code Name
Culture Media, Non-Selective And Non-Differential
Public Device Record Key
6fb1cbac-5821-4ccd-96c5-dccec6643e5e
Public Version Date
July 18, 2019
Public Version Number
2
DI Record Publish Date
September 12, 2018
Package DI Number
B08812634
Quantity per Package
20
Contains DI Package
B08812630
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box