Duns Number:039981550
Device Description: Thionin Acetate, 1:50,000 dilution, for Brucella, 20ml fill, 20x125mm tube, order by the p
Catalog Number
Z036
Brand Name
N/A
Version/Model Number
Z036
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 02, 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
55baa1f8-8cea-4f42-bf19-f90f87116f48
Public Version Date
June 03, 2022
Public Version Number
2
DI Record Publish Date
June 09, 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 |