Duns Number:045361136
Device Description: A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum.
Catalog Number
S2960-600
Brand Name
Sirrus® Gamma-GT LiquiColor®
Version/Model Number
S2960-600
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
Yes
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
JQB
Product Code Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Public Device Record Key
7e221e2f-c31a-4861-b151-bca982f1ccb5
Public Version Date
April 16, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |