Duns Number:039981550
Device Description: Tryptic Soy Agar (TSA) (without plate label, orientation tabs, and logo), 15x100ml Plate, Tryptic Soy Agar (TSA) (without plate label, orientation tabs, and logo), 15x100ml Plate, 23ml. Hardy Diagnostics Tryptic Soy Agar is recommended for use as a general growth medium for the isolation and cultivation of microorganisms. This medium is also recommended for use in the cultivation, storage, maintenance and transportation of pure cultures of microorganisms.
Catalog Number
G62
Brand Name
N/A
Version/Model Number
G62
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2022
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
0852c373-b6cd-4120-a15c-c5e0c038a292
Public Version Date
April 22, 2022
Public Version Number
2
DI Record Publish Date
May 20, 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 |