Duns Number:039981550
Device Description: LJ (Lowenstein Jensen) with Pyruvate, 50ml plastic HardyFlask™, order by the package of 20 LJ (Lowenstein Jensen) with Pyruvate, 50ml plastic HardyFlask™, order by the package of 20Lowenstein Jensen Media are recommended for use in the cultivation and isolation of Mycobacterium species.
Catalog Number
X19
Brand Name
HardyFlask™
Version/Model Number
X19
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
7710cb6c-348b-4d19-b335-89510521344d
Public Version Date
June 16, 2020
Public Version Number
1
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 |