Duns Number:070371210
Device Description: For the quantitative determination of Aspartate Aminotransferase (AST) in human serum usin For the quantitative determination of Aspartate Aminotransferase (AST) in human serum using the Mindray BS-200 analyzer. 2 x 40 ml, 2 x 10 ml
Catalog Number
AST600
Brand Name
AST / BS200
Version/Model Number
AST600
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
K941132
Product Code
CIT
Product Code Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Public Device Record Key
79e28ab0-5f67-4ece-b942-dee2d5167216
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |