Duns Number:605213545
Device Description: InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of derm InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.
Catalog Number
21-593-001
Brand Name
InTray DM-FungID
Version/Model Number
1593
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
4095c25a-987f-4304-bff3-b0833b2a3606
Public Version Date
February 18, 2020
Public Version Number
1
DI Record Publish Date
February 10, 2020
Package DI Number
B08815934
Quantity per Package
20
Contains DI Package
B08815930
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box