Duns Number:045623154
Device Description: Pointe AST Reagent packaged for use on the Mindray BA800. 5 x 67ml R1, 5 x 17ml R2. For Pointe AST Reagent packaged for use on the Mindray BA800. 5 x 67ml R1, 5 x 17ml R2. For the quantitative determination of Aspartate Aminotransferase (AST) in human serum.
Catalog Number
16-A7561-420
Brand Name
Pointe AST Reagent
Version/Model Number
16-A7561-420
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
9cc0b097-f905-4df7-9d8f-aa1c0897e34b
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 30, 2021
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 |