PMA P930036S006
- Device
- ADVIA CENTAUR AFP ASSAY
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S006
- Product code
- LOK
- Decision date
- 2018-04-13
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval for the migration of the ADVIA Centaur AFP assay to the ADVIA Centaur XPT system
Current openFDA PMA Record#
- Device
- ADVIA CENTAUR AFP ASSAY
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S006
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2018-04-13
- Decision code
- APPR
- Date received
- 2015-07-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the migration of the ADVIA Centaur AFP assay to the ADVIA Centaur XPT system