The SEFRIA Fentanyl Urine Enzyme Immunoassay (Immunalysis) has been granted 510(k) clearance by the FDA. The first-ever fentanyl enzyme to receive 510(k) clearance, SEFRIA has been cleared for the qualitative detection of fentanyl in urine.
A representative from Immunalysis said in a press statement that the clearance of SEFRIA would allow health care providers to more accurately screen their patients for fentanyl.
Previously, forensic laboratories were the only facilities equipped with fentanyl