Duns Number:039981550
Device Description: Wallenstein, 20x125mm Tube, 10ml Slant. Hardy Diagnostics Wallenstein Media are recommende Wallenstein, 20x125mm Tube, 10ml Slant. Hardy Diagnostics Wallenstein Media are recommended for use in the cultivation and isolation of mycobacteria other than tuberculosis. It is particularly useful in the recovery of Mycobacteria avium complex.
Catalog Number
C61
Brand Name
N/A
Version/Model Number
C61
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
eb0b94ef-5d2a-401d-a2f6-097e1c7f5212
Public Version Date
May 22, 2020
Public Version Number
1
DI Record Publish Date
May 14, 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 |