Duns Number:463625602
Device Description: The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System.For in vitro diagnostic use.
Catalog Number
210393
Brand Name
DG Gel 8 Neutral
Version/Model Number
210393
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
-
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
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
85ef1d7f-e9d5-4d40-884c-1339a24a7632
Public Version Date
November 24, 2020
Public Version Number
1
DI Record Publish Date
November 16, 2020
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 |