Immucor’s Lifecodes Assays, Match It! Software Get FDA’s 510(k) Clearance
Immucor has received FDA’s 510(k) clearance for its Luminex Lifecodes single antigen Class I and Class II assays.
The antigen-based assays are used to determine a potential organ donor’s suitability for transplant.
The accompanying Match It! antibody software, which has also received FDA clearance, features tools to help determine antibody specificity and multiple reporting formats, the company said.