ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
FDA premarket approval P930036/S004 · decided 2012-08-14
Approval details
- PMA number
- P930036
- Supplement
- S004
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2012-02-15
- Decision date
- 2012-08-14
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF A LOT SPECIFIC MASTER CURVE IN THE QUALITY CONTROL TESTING OF THE ANTI-AFP ANTIBODY.
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