DevicePMAs@therightstef:P980041_S003 JSONTXT 11 Projects

Approval for expanding the use of access afp reagents on the unicel dxl 800 access immunoassay system. The device, as modified, will be marketed under the trade name access afp immunoassay system and is indicated for the quantitative determinations of alpha-fetoprotein (afp) in: 1) human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2) maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ontd). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ontd. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amiography.