PMA P930036S021
- Device
- Atellica IM Alpha Fetoprotein (AFP)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S021
- Product code
- LOK
- Decision date
- 2024-02-08
- Classification
- Immunology
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- migration of the ADVIA Centaur AFP assay to the Atellica CI Analyzer
Current openFDA PMA Record#
- Device
- Atellica IM Alpha Fetoprotein (AFP)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S021
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2024-02-08
- Decision code
- APPR
- Date received
- 2023-08-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- migration of the ADVIA Centaur AFP assay to the Atellica CI Analyzer