Duns Number:463625602
Device Description: The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on th The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells of two separate blood samples.For use with the DG Gel System.For in vitro diagnostic use.
Catalog Number
210387
Brand Name
DG Gel 8 Rh Pheno
Version/Model Number
210387
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 2016
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
6a617207-b996-41ed-aead-0c7083d1a28e
Public Version Date
January 28, 2021
Public Version Number
3
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 |