Duns Number:227530649
Catalog Number
-
Brand Name
GLUTATHIONE REDUCTASE (GLUT RED)
Version/Model Number
GR2368
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQF
Product Code Name
Assay, Glutathione Reductase
Public Device Record Key
6648f0e0-9414-4165-ac8e-8a851e832430
Public Version Date
June 11, 2019
Public Version Number
1
DI Record Publish Date
June 03, 2019
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 | 305 |
2 | A medical device with a moderate to high risk that requires special controls. | 258 |