Our IgE test is "Substantially Equivalent (SESE) to other IgE tests that fall under the Class 2 designation. Some IgE diagnostic devices test blood samples. Our device tests tear drops.
It appears all IgE tests fall under the.
Division of Immunology and Hematology Devices (DIHD) and seems all are coded as Class 2.
There is an Ophthalmics division under DIHD.
TPLC - Total Product Life Cycle
Device : Ige, Antigen, Antiserum, Control
Product Code DGC
Regulation Number 866.5510
Device Class 2
Substantially Equivalent (SESE)
HOWEVER. I believe our Lactoferrin test has already been updated as a Class-1 (Waived) test as of December 22, 2023. If I am reading correctly.
News 
Market Data 
Discover 
