- Device
- ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S004
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2012-08-14
- Decision code
- APPR
- Date received
- 2012-02-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE IMPLEMENTATION OF A LOT SPECIFIC MASTER CURVE IN THE QUALITY CONTROL TESTING OF THE ANTI-AFP ANTIBODY.