The ZytoLight SPEC MAML2 Dual Color Break Apart Probe (PL5) is intended to be used for the qualitative detection of translocations involving the human MAML2 gene at 11q21 in formalin-fixed, paraffin-embedded specimens, such as mucoepidermoid carcinoma (MEC), by fluorescence in situ hybridization (FISH). The probe is intended to be used in combination with the ZytoLight FISH-Tissue Implementation Kit (Prod. No. Z-2028-5/-20). The product is intended for professional use only. All tests using the product should be performed in a certified, licensed anatomic pathology laboratory under the supervision of a pathologist/human geneticist by qualified personnel. The probe is intended to be used as an aid to the differential diagnosis of MEC and therapeutic measures should not be initiated based on the test result alone.