Duns Number:463625602
Device Description: The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D and K antigens on the surface of red blood cells of human blood samples.For use with the DG Gel System.For in vitro diagnostic use.
Catalog Number
210383
Brand Name
DG Gel 8 ABO/Rh+Kell
Version/Model Number
210383
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2022
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
8b8ca24c-c7ea-49e0-bab3-27e20540bbd6
Public Version Date
January 31, 2022
Public Version Number
3
DI Record Publish Date
March 15, 2021
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 |