Shenzhen Superbio Technology Co., LTD. (Superbio) has received clearance from the US Food and Drug Administration (FDA) on one of the first point-of-care instruments intended for qualitative detection of fentanyl in human urine and has fully released authorization to Bioeasy USA, Inc. (Bioeasy) of this product in the United States of America.
Carolina Liquid Chemistries Corp. (CLC) has partnered with Bioeasy and will be the distributor of the product in the USA under the brand name RYAN.
The Carolina Liquid Chemistries Corp. Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Carolina Liquid Chemistries Corp. immunofluorescence analyzer RYAN. The test provides a preliminary test result; a more specific alternative chemical method must be used in order to obtain a confirmed analytical result.
The Carolina Liquid Chemistries Corp. immunofluorescence analyzer RYAN is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to perform in vitro diagnostic tests on clinical urine specimens. This analyzer can be used in a laboratory or in a point-of-care setting.
The Ryan analyzer with the Carolina Liquid Chemistries Corp. Fentanyl Urine Detection Kit uses the principle of competitive and fluorescence immunochromatography assay and uses fluorescence microspheres-labeled monoclonal antibody as the indicator marker to qualitatively detect fentanyl in human urine.