Duns Number:039981550
Device Description: Selenite Cystine Broth, 20mlFor the selective enrichment of Salmonella spp. Cystine enhanc Selenite Cystine Broth, 20mlFor the selective enrichment of Salmonella spp. Cystine enhances growth of Salmonella spp.
Catalog Number
K120
Brand Name
N/A
Version/Model Number
K120
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
JSJ
Product Code Name
Culture Media, Selective And Non-Differential
Public Device Record Key
e9e19510-a3e0-42af-8575-bfaf6aa407a7
Public Version Date
March 11, 2022
Public Version Number
1
DI Record Publish Date
March 03, 2022
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 |