Duns Number:039981550
Device Description: Caffeic Acid Agar Slant (Bird Seed Agar), for Cryptococcus, 16x100mm tube, order by the pa Caffeic Acid Agar Slant (Bird Seed Agar), for Cryptococcus, 16x100mm tube, order by the package of 20For the selective isolation and differentiation of Cryptococcus neoformans and Cryptococcus gattii. Also known as Bird Seed Agar or Niger Seed Agar.
Catalog Number
L13
Brand Name
N/A
Version/Model Number
L13
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 18, 2021
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
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
8943a18a-bb80-4a50-8e8b-fa31efb59ddd
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
June 03, 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 |