Duns Number:463625602
Device Description: The DG Gel 8 Anti-D card is for the determination of D antigen on the surface of red blood The DG Gel 8 Anti-D card is for the determination of D antigen on the surface of red blood cells of eight human blood samples.For use with the DG Gel System. For in vitro diagnostic use.
Catalog Number
210202
Brand Name
DG Gel 8 Anti-D
Version/Model Number
210202
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
19e43684-6233-43f4-a8b2-fe99a02cbbfd
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 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 |