IMMULITE AFP ASSAY
FDA premarket approval P010007/S009 · decided 2012-11-08
Approval details
- PMA number
- P010007
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- IMMULITE AFP ASSAY
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2012-05-30
- Decision date
- 2012-11-08
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR ELIMINATING THE TEST REDUNDANCY BY USING ONLY THE BIORADLYPHOCHECK IMMUNOASSAY PLUS CONTROLS IN IN-PROCESS COMPONENT TESTING, POST-FILL TESTING AND FINAL KIT COMBINATION TESTING FOR THE ASSESSMENT OF IMMULITE AFP, FREE PSA, AND PSA/3RD GENERATION PSA ASSAY PERFORMANCE.
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