Duns Number:039981550
Device Description: Purple Broth with Adonitol, 10mL, 16x125mm tube, 20 tubes/boxFor the differentiation of mi Purple Broth with Adonitol, 10mL, 16x125mm tube, 20 tubes/boxFor the differentiation of microorganisms based on acidification of carbohydrates or other compounds.
Catalog Number
Y101
Brand Name
N/A
Version/Model Number
Y101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 25, 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
757a1660-d967-48bf-9327-ac84e8d936b0
Public Version Date
October 26, 2021
Public Version Number
2
DI Record Publish Date
June 08, 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 |