Duns Number:276816717
Device Description: Trypcase Soy broth is a culture medium for the growth of most non-fastidious micro-organis Trypcase Soy broth is a culture medium for the growth of most non-fastidious micro-organisms (bacteria and fungi)
Catalog Number
-
Brand Name
Trypcase Soy Broth
Version/Model Number
42100
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)
Yes
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
b139b28c-e1e1-4343-9100-4c6093cb7e90
Public Version Date
November 21, 2019
Public Version Number
2
DI Record Publish Date
July 19, 2019
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |