Duns Number:463625602
Device Description: The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglobulin Test The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglobulin Test of two different human blood samples. It allows to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions.For use with the DG Gel System.For in vitro diagnostic use.
Catalog Number
-
Brand Name
DG Gel 8 Direct Coombs
Version/Model Number
210129
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
-
Product Code Name
-
Public Device Record Key
e333cede-a891-4281-a447-1f719e47506e
Public Version Date
July 18, 2022
Public Version Number
1
DI Record Publish Date
July 08, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |