ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P980041/S008 · decided 2006-05-16
Approval details
- PMA number
- P980041
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2006-04-10
- Decision date
- 2006-05-16
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL FOR THE ACCESS AFP REAGENTS FOR USE ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS. THE ACCESS AFP ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR USE WITH THE ACCESS IMMUNOASSAY SYSTEMS FOR THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN: 1) HUMAN SERUM, AS AN AID IN THE MANAGEMENT OF PATIENTS WITH NON-SEMINOMATOUS TESTICULAR CANC
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