Duns Number:014210494
Device Description: AST Reagent 8 X 67 mL + 2 X 67 mL
Catalog Number
UV085-1200
Brand Name
Synermed®
Version/Model Number
UV085-1200
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
K915555
Product Code
CIT
Product Code Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Public Device Record Key
f82f9e90-7ae6-4fb6-bb37-dc90bbb37905
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 28, 2017
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 | 71 |
2 | A medical device with a moderate to high risk that requires special controls. | 130 |