ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA premarket approval P980041/S006 · decided 2004-08-04
Approval details
- PMA number
- P980041
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2004-07-29
- Decision date
- 2004-08-04
- Days to decision
- 6 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL OF THE ADDITION OF AN ASSAY PROTOCOL FILE TO THE ASSAY SOFTWARE OF THE ACCESS AFP REAGENT FOR ON-BOARD SYSTEM AUTO-DILUTION OF HUMAN SERUM AND AMNIOTIC FLUID SAMPLES FOR ALL ACCESS IMMUNOASSAY ANLAYZERS (ACCESS, ACCESS 2, SYNCHRON LXI 725 AND UNICEL DXI 800). THE ACCESS AFP ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE USE WITH THE ACCESS IMMUNOASSAY SYSTEMS FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1) HUMAN SERUM, AS AN AID IN THE MANAGE
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