Duns Number:045623154
Device Description: Pointe AST packaged for use on the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitativ Pointe AST packaged for use on the BS480 Analyzer. 5x60mL, 5x15mL Kit. For the quantitative determination of Aspartate Aminotransferase (AST) in human serum on the BS480 Analyzer.
Catalog Number
14-A7561-375
Brand Name
Pointe AST on the BS480 Analyzer
Version/Model Number
14-A7561-375
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
21bbd67e-7012-413e-897a-2608034a6958
Public Version Date
June 05, 2020
Public Version Number
1
DI Record Publish Date
May 28, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |