Haemoglobin IVDs

Intended purpose

Sickle SCAN®: The Sickle SCAN® test is a lateral flow chromatographic qualitative immunoassay to aid in the rapid diagnosis of sickle cell disorders of hemoglobins A, S, and C using fingerstick or venipuncture whole blood samples or EDTA blood sample. User will be a clinical professional such as a doctor, physician assistant, nurse, clinical or medical assistant, or laboratory technician. Sickle SCAN® EC95 POSITIVE CONTROL KIT: The Sickle SCAN® EC95 Positive Control Kit is intended to be used for validating efficacy and quality of Sickle SCAN rapid test devices. User will be a clinical professional such as a doctor, physician assistant, nurse, clinical or medical assistant, or laboratory technician.