Duns Number:463625602
Device Description: The DG Gel 8 AB (x4) card is for the determination of human A and B antigens on the surfac The DG Gel 8 AB (x4) card is for the determination of human A and B antigens on the surface of red blood cells of four separate blood samples.For use with the DG Gel System.For in vitro diagnostic use.
Catalog Number
210386
Brand Name
DG Gel 8 AB (x4)
Version/Model Number
210386
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
50228b88-fa36-413d-b22c-22b2b4a99d5e
Public Version Date
March 23, 2021
Public Version Number
1
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 |