Duns Number:039981550
Device Description: Potato Dextrose Agar, USP, deep fill, 15x100mm plate, order by the package of 10Potato Dex Potato Dextrose Agar, USP, deep fill, 15x100mm plate, order by the package of 10Potato Dextrose Agar (PDA), USP is recommended for the cultivation of yeast and mold, and for the inducement of sporulation in non-clinical samples.Potato Dextrose Agar (PDA), USP is formulated as outlined by the U.S. Pharmacopoeia for the preparation of test strains used in microbial enumeration tests.
Catalog Number
W60
Brand Name
N/A
Version/Model Number
W60
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
e97832a2-cdd2-4f3c-8118-65d4ffa0e633
Public Version Date
June 16, 2020
Public Version Number
1
DI Record Publish Date
June 08, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |