Duns Number:061446282
Device Description: Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing.
Catalog Number
0007865
Brand Name
Gamma EGA Kit
Version/Model Number
0007865
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)
Yes
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
BK960090
Product Code
KSG
Product Code Name
Media, Potentiating For In Vitro Diagnostic Use
Public Device Record Key
cf049be4-49fd-4005-8bc8-977a2407103e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 14, 2016
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| U | Unclassified | 3 |