Duns Number:039981550
Device Description: LJ (Lowenstein Jensen) with Ferric Ammonium Citrate, 50ml plastic HardyFlask™, order by th LJ (Lowenstein Jensen) with Ferric Ammonium Citrate, 50ml plastic HardyFlask™, order by the package of 20(Lowenstein Jensen with Ferric Ammonium Citrate) For the cultivation of Mycobacterium spp.
Catalog Number
X21
Brand Name
HardyFlask™
Version/Model Number
X21
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
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
804b326e-268a-4029-9691-44382a86d538
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 |