Duns Number:039981550
Device Description: Basic Fuchsin, 1:50,000 dilution, for Brucella, 20ml fill, 20x125mm tube,For the speciatio Basic Fuchsin, 1:50,000 dilution, for Brucella, 20ml fill, 20x125mm tube,For the speciation of Brucella.
Catalog Number
Z006
Brand Name
N/A
Version/Model Number
Z006
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
JSJ
Product Code Name
Culture Media, Selective And Non-Differential
Public Device Record Key
78d587d4-0cd4-4d37-9ed5-62395736f5bb
Public Version Date
June 03, 2022
Public Version Number
2
DI Record Publish Date
June 25, 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 |