Duns Number:064608573
Device Description: ALT/GPT - ADVIA Chem. - RGT - 7x360 tests
Catalog Number
7501976
Brand Name
ADVIA® Chemistry ALT(GPT) Reagents
Version/Model Number
10309500
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CKA
Product Code Name
NADH OXIDATION/NAD REDUCTION, ALT/SGPT
Public Device Record Key
fb30378d-5ee6-446e-93b7-818cdd63b704
Public Version Date
November 18, 2021
Public Version Number
2
DI Record Publish Date
September 24, 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 | 363 |
2 | A medical device with a moderate to high risk that requires special controls. | 829 |
3 | A medical device with high risk that requires premarket approval | 57 |
U | Unclassified | 7 |