Duns Number:605213545
Device Description: Recommended by the American Public Health Association for plate counts of yeasts and molds Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
Catalog Number
21-293-001
Brand Name
InTray® PDA
Version/Model Number
1293
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
1f2cc956-0882-4a79-9092-8846d1e2f328
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 12, 2018
Package DI Number
B08812934
Quantity per Package
20
Contains DI Package
B08812930
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box