Access Afp Immunoassay System
FDA premarket approval P980041 · Kit, Test, Alpha-Fetoprotein for Neural Tube Defects
PMA numberP980041
Approval
- Applicant
- Beckman Coulter, Inc.
- Received
- October 16, 1998
- Decision date
- February 8, 1999 (APPR)
- Supplements
- 47, latest November 3, 2025
- Product code
- LOK – Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
Approval order statement
Approval for the Access(R) AFP Reagents on the Access(R) Immunoassay Analyzer. The Access(R) AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access(R) Immunoassay System for the quantitative determination fo alpha-fetoprotein (AFP) in: 1)Human seru, as an aid in 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). The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.