The Folate (FA) Rapid Test Device (the “uncut sheet” format for manufacturing use) is a fluorescence immunochromatographic assay intended for the quantitative determination of folate (folic acid) concentration in human serum, plasma, or whole blood specimens.

This test is intended for in vitro diagnostic professional use and serves as an aid in the assessment of folate status, including the screening and diagnosis of folate deficiency and the monitoring of patients at risk of folate insufficiency .

The device provides quantitative screening results. Test results are intended for clinical reference only. The test result should be interpreted in conjunction with patient history, clinical presentation, and other laboratory findings. 

This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.