Duns Number:045623154
Device Description: Pointe Scientific, Inc. GGT Reagent is for the quantitative kinetic determination of gamma Pointe Scientific, Inc. GGT Reagent is for the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Olympus analyzers. For in vitro diagnostic use only. 5 x 42ml, 5 x 17ml
Catalog Number
OG959-295
Brand Name
Pointe Scientific, Inc. GGT
Version/Model Number
OG959-295
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
K973157
Product Code
JQB
Product Code Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Public Device Record Key
70b0a021-0226-4c0c-9f37-5f48d46a48bf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |