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.
Gamma EGA Kit - 0007865
Device Description
A collection of reagents and other associated materials intended to be used for the elution of antibodies bound to antigens present on the surface of red blood cells in a clinical specimen.
Environmental Conditions
- 30.00
- 15.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KSG
Device Name: Media, Potentiating For In Vitro Diagnostic Use
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.9600
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 10888234000877
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A