Duns Number:463625602
Device Description: The DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the su The DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components.For use with the DG Gel System.For in vitro diagnostic use.
Catalog Number
210391
Brand Name
DG Gel 8 T/S Mono
Version/Model Number
210391
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 02, 2019
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
611302aa-896e-4e7d-bcba-6c8a7135cd1e
Public Version Date
October 19, 2021
Public Version Number
6
DI Record Publish Date
July 22, 2015
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 |