Duns Number:989964119
Device Description: Activated Aspartate Aminotransferase 4800 Tests
Catalog Number
08L9144
Brand Name
ARCHITECT
Version/Model Number
08L9144
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
63f75bdf-4a67-4f0e-bb36-7ba2ba4a7236
Public Version Date
June 01, 2022
Public Version Number
1
DI Record Publish Date
May 24, 2022
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 | 110 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |