Duns Number:545261989
Catalog Number
-
Brand Name
Aspartate Aminotransferase Kit (Colorimetric Method )
Version/Model Number
None
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CIT
Product Code Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Public Device Record Key
355db410-1462-411e-8e04-bc7cf629a6dd
Public Version Date
March 15, 2019
Public Version Number
1
DI Record Publish Date
March 07, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |