Duns Number:039981550
Device Description: HardyCHROM Group A Strep Agar (RSR)A chromogenic medium recommended for the selective cult HardyCHROM Group A Strep Agar (RSR)A chromogenic medium recommended for the selective cultivation and differential isolation of Group A Streptococcus (S. pyogenes) from specimens based on colony color. Some ingredients are very light sensitive. Store and incubate in the dark.
Catalog Number
GA337
Brand Name
HardyCHROM
Version/Model Number
GA337
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 27, 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
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
f0d59c1f-f193-4498-8936-115768f19415
Public Version Date
April 28, 2022
Public Version Number
2
DI Record Publish Date
April 07, 2021
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 |