Duns Number:039981550
Device Description: Corn Meal Agar with Tween® 80 Deep, for chlamydospores, 18ml deep, 20x125mm pour tube, ord Corn Meal Agar with Tween® 80 Deep, for chlamydospores, 18ml deep, 20x125mm pour tube, order by the package of 20For the cultivation of fungi. Induces chlamydospore formation by Candida spp.
Catalog Number
Q12
Brand Name
N/A
Version/Model Number
Q12
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
JSH
Product Code Name
Culture Media, Non-Selective And Differential
Public Device Record Key
abf63c82-be14-4628-bffe-fd802d45371a
Public Version Date
June 12, 2020
Public Version Number
1
DI Record Publish Date
June 04, 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 |