AFP IMMULITE ASSAY
FDA premarket approval P010007/S006 · decided 2011-09-07
Approval details
- PMA number
- P010007
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AFP IMMULITE ASSAY
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2011-08-08
- Decision date
- 2011-09-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- THE CHANGE IS TO IMPLEMENT USE OF A FULLY AUTOMATED FILLING AND PACKAGING LINE FOR THE IMMULITE CHEMILUMINESCENT SUBSTRATE. THE CURRENT METHOD OF FILLING AND PACKAGING THE SUBSTRATE IS BY USE OF A SEMI-AUTOMATED LINE. FULL AUTOMATION OF THE LINE ELIMINATES REPETITIVE ACTIONS THAT ARE PERFORMED MANUALLY.
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