Duns Number:605213545
Device Description: An enriched dermatophyte medium used in the detection of dermatophytes from clinical speci An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
Catalog Number
22-063-000
Brand Name
InTray® DM
Version/Model Number
2063
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
5fe6a40a-c01e-4abc-bec4-5aa0d95ac6a4
Public Version Date
July 18, 2019
Public Version Number
2
DI Record Publish Date
September 13, 2018
Package DI Number
B08820634
Quantity per Package
20
Contains DI Package
B08820630
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box